Insulet: Undisclosed Patient Deaths “Life-Threatening, Especially for Children,” Price Target $15

Highlights
  • PODD enjoys an unexplained premium, we see 42% downside before considering any of the following issues with its sole product, the Omnipod insulin pump
  • Irrefutable evidence of 44 Omnipod patient deaths, FDA-acknowledged under-reporting factor suggests patient deaths could be as high as 4,400
  • Numerous allegations by a whistleblower: patient death cover-up, undisclosed settlement
  • Multiple third parties and parents of diabetic children warn about Omnipod - “life-threatening, especially for children”
  • PODD recently confirmed approximately 28,000 children (30% of patient base) use the Omnipod
  • Omnipod product defects clearly exist and have not been resolved 5 years later
  • Post-recalls and design modification, PODD’s FDA adverse events have climbed rather than decline both in total and for the needle defect
  • Risks associated with 20-month old FDA investigation ignored by sell-side analysts, we confirmed investigation remains open
  • Competition is heating up, new innovative products from Medtronic and J&J arriving by end of ’16
  • Serious fraud allegations – we see signs and evidence that current and prior management have deceived patients, investors and perhaps the FDA

November 15, 2016

9:59 A.M. EDT

 

I. Introduction to PODD

 

We began our research of Insulet Corporation (“PODD”) in August 2016. We were intrigued by PODD’s seemingly extreme valuation as well as serious allegations of fraud that had been made against PODD’s prior management. These attributes of a public company will always peak our interest. However, soon after we began our research we uncovered a large number of patient deaths involving PODD’s sole product, the Omnipod, as well as allegations and evidence of the Omnipod being "life-threatening" to children. We’ve now spent almost three months on this report. However, PODD struck a cord with us. We do not believe PODD management have the best interests of its patients in mind. PODD’s patient base includes a large number of children. The current situation is just absolutely unacceptable.

 

The following is an expanded summary of the bullet points presented above.

 

1. We see the market’s valuation of PODD stock to be “extreme.” This is a premium pricing of a company that even prior to this report is unexplained. Subsequent to this report, we believe a discount rather than a premium is warranted, for the reasons outlined below. See Section II of this report for additional discussion of this topic.

 

2. Patient deaths are serious business for any medical technology or biotech company. The lack of disclosure of the full details of PODD’s patient deaths to investors, patients and the government is beyond reprehensible. In this report we present a total of 44 patient deaths associated with PODD patients that were included in an FDA database of 8,236 adverse event reports (“FDA Reports”) associated with PODD. We feel strongly that of the research we obtained, the 4 patient deaths listed below are likely due to the Omnipod to some degree. A summary excerpt of our research of these 4 deaths is as follows. We urge all readers to review these FDA Reports by clicking on the links referenced below this image.

 

 

        Patient death #1: 4270189

        Patient death #2: 3495620

        Patient death #3: 3644443

        Patient death #4: 5381402

 

These are just 4 of the 44 patient deaths we obtained evidence about. We note that the true number of Omnipod patient deaths is understated due to an under-reporting phenomenon associated with the FDA Report database that the FDA itself has confirmed exists. When the under-reporting is considered, the true number of undisclosed Omnipod patient deaths could be as high as 4,400.

 

A few excerpts from this report related to this topic are as follows:

 

  • - “The patient’s nurse/trainer reported that the patient was dead and her family is very unhappy. They said the pump had never worked but that this was due to the pods continually falling off.”
  • - “…His pt was receiving erroneously low readings using the Omnipod…She stated the date of death and that the deceased was found wearing a pod.”
  • - “The medical examiner’s office called on (B)(6) 2011 to report that a customer was found deceased in his home. He was found wearing a POD and a Dexcom CGM.”
  • - “The police was then called and upon their arrival at his house he was found dead in a chair in the living room. The POD was found beeping; it was teared off the body and laid next to the corpse.”

 

See Section IV of this report for additional discussion of this topic.

 

3. We obtained evidence of the involvement of a whistleblower who alleged that patient death #1 was due to the Omnipod and that there was a subsequent cover-up of the patient death. It appears he or she was then paid off.

 

A few excerpts from this report related to this topic are as follows:

 

  • - “The hospital did however download partial data showing the pump failure just prior to her death.”
  • - “It is more probable than not that the device caused or contributed to her death.”
  • - “I was made aware of the incident by XX also of Ypsomed who stated that XX never reported it (buried it)”
  • - “I exposed it shortly after finding out and have since accepted a settlement.” We are entirely unsure why anyone would be paid a settlement in connection with a patient’s death.
  • - “The event was covered up on many levels for which I hold evidence.” We note the death was not reported until two (2) years after the death.

 

See Section IV of this report for additional discussion of this topic.

 

4. We obtained evidence and allegations by multiple third parties that the Omnipod is "life-threatening" to children. A few excerpts from this report are as follows:

 

  • - “Omnipod is life-threatening, especially for children.”
  • - “blood glucose would be a very high number damaging her eyes, kidneys, veins, heart…everyone of these issues is life-threatening and could result in death”
  • - “…(by this time I have no faith whatsoever that my child is getting insulin.)…even if it was delivering basal insulin, the pod was not able to deliver insulin boluses which keep a child alive when they eat any food with carbohydrates.”
  • - “I am so afraid that a child or someone who is unaware of the issue will go on a flight and have a very serious hypoglycemic event.”
  • PODD’s President and Chief Commercial Officer recently confirmed 30% of PODD’s patient base are children. We calculate a total of approximately 28,000 children now use the “life-threatening” Omnipod and are at risk every day.

 

See Section V of this report for additional discussion of this topic.

 

5. PODD has one severe defect it has been dealing with for 5 years and has yet to resolve it. Another product defect with its PDM appears as though it too soon could cause another recall. A few excerpts from this report are as follows:

 

  • - “In sum, the accusation that we had needle firing issues is absolutely true.”
  • - “… The customer's mother reported that the needle deployed 10 minutes after it was supposed to.”
  • - “Insulet's almost disinterested response is a reason to doubt that they will diagnose the cause of these malfunctions. Their focus is "how soon would you like to receive replacement pots?" despite it being clear that replacement pods are a bad idea now.”
  • - “One Insulet employee that she knew actually stopped using the Eros altogether because they did not trust the product.”

 

See Section VI of this report for additional discussion of this topic.

 

Sections VII, VIII, IX and X outline additional research involving the continued increase in adverse events PODD patients have reported, PODD’s regulatory risk, the competitive landscape and fraud allegations against management, respectively. Section XI discusses the future of PODD and our considerations related to its valuation.

 

II. PODD stock currently enjoys an unexplained 42% premium prior to considering the findings we outline in this report

 

We reviewed a New York University ongoing study (the “NYU Study”) to obtain third party data on medical device sector valuation multiples. We then utilized the data in the NYU Study to consider the market’s valuation of PODD shares. Our analysis is presented in the following chart.

 

 

We see no valid reason why PODD should be given a premium valuation within its sector. We provide a detailed discussion of PODD’s valuation within the last section of this report, entitled “Ticking Time-bomb.”

 

III. A Brief Overview of PODD’s sole product – the Omnipod

 

PODD’s sole product is the Omnipod, as seen in the image below. The Omnipod system includes a patch-like device that is meant to adhere to the skin of a diabetes patient and deliver insulin into the patient’s bloodstream using a very thin needle, known as a “cannula.” The Omnipod personal diabetes manager (“PDM”) is a wireless smartphone-like device the diabetes patient uses to control the Omnipod. At the end of each 3-day period the Omnipod is disposed of by the patient and a new Omnipod is meant to be adhered to their skin.

 

 

 

Source

 

The Omnipod system is described in additional detail at PODD’s website.

 

While researching the Omnipod device we reviewed the U.S. Food and Drug Administration’s (“FDA”) manufacturer and user facility device experience database (“MAUDE”) to obtain every adverse event report (“FDA Report”) associated with the Omnipod. We uncovered a variety of quantitative and qualitative content within a total of 8,236 FDA Reports which led us to conduct additional diligence to understand Omnipod malfunctions and injuries associated with children, Omnipod patient deaths, and specific FDA Report data and data trends. We will detail the various findings throughout this report.

 

IV. We uncovered FDA data suggesting 39 patient deaths could be tied to the Omnipod, we feel strongly that 4 of the patient deaths are tied to the Omnipod, another 35 patient deaths may also be connected

 

We uncovered a variety of content within the FDA Reports which led us to conduct additional diligence to understand Omnipod patient deaths. We found a total of 44 patient deaths. We provide our detailed findings below.

 

Red: 4 patient deaths that we feel strongly are tied to the Omnipod

Yellow: 35 patient deaths may also be connected

 

 

 

1. We uncovered specific direct allegations by a whistleblower that a PODD patient died as a result of the Omnipod, that the whistleblower was paid-off and that there was a cover-up associated with this patient death. In this FDA Report PODD seems to effectively conclude the Omnipod device may be to blame yet PODD has not publicly acknowledged its Omnipod has caused any patient deaths. The relevant quotes in the FDA Report are as follows:

 

“The hospital did however download partial data showing the pump failure just prior to her death.”

 

“It is more probable than not that the device caused or contributed to her death.”

 

“I was made aware of the incident by XX also of Ypsomed who stated that XX never reported it (buried it)”

 

“I exposed it shortly after finding out and have since accepted a settlement.”

 

“The event was covered up on many levels for which I hold evidence.”

 

These quotes are highlighted in the image below.

 

 

Source

 

We noted through review of the FDA Report that PODD appears to have confirmed the Omnipod patient death subsequent to “multiple failures of the pump prior to her death.” A whistleblower filed an additional report with the FDA to allege the cover-up of the patient death and the settlement and pay-off of the whistleblower.

 

Questions all shareholders should be asking:

 

  • - Why is a settlement and pay-off associated with a patient death?
  • - What were the terms of this settlement?
  • - How often, why and to what dollar value annually has PODD entered into settlements with patients, whistleblowers and others?
  • - Why did PODD determine it did not need to disclose this patient death within its filings with the SEC?
  • - Why did PODD wait 2 full years before filing this FDA Report with the FDA?

 

2. We uncovered an FDA Report apparently filed by PODD that suggested a “device problem” was associated with a patient death. The relevant content is highlighted in the image below.

 

“The patient’s nurse/trainer reported that the patient was dead and her family is very unhappy. They said the pump had never worked but that this was due to the pods continually falling off.”

 

 

Source

 

Questions all shareholders should be asking:

 

  • - According to this FDA Report, the Omnipod devices were “continually falling off” of the patient causing her BG levels to go high which caused her to then try “correcting with an insulin pen.” The issues all started with the Omnipod not working and “continually falling off” of the patient. How could this be construed as anything other than a patient death due to an Omnipod device failure?
  • - Why did PODD determine it did not need to disclose this patient death within its filings with the SEC?

 

3. We uncovered an FDA Report apparently filed by PODD that suggested a “device problem” was associated with a patient death.  The relevant content is highlighted in the image below.

 

“…His pt was receiving erroneously low readings using the Omnipod…She stated the date of death and that the deceased was found wearing a pod.”

 

 

Source

 

Questions every shareholder should be asking:

 

  • - According to this FDA Report, the Omnipod PDM device was providing “erroneously low readings” of the patient’s insulin levels. PODD attempts to suggest that Abbott is blame for faulty test strips but then a physician tested the strips and determined they were providing readings “within range.” How could this be construed as anything other than a patient death due to an Omnipod device failure?
  • - Why did PODD determine it did not need to disclose this patient death within its filings with the SEC?

 

4. We uncovered an FDA Report apparently filed by PODD that suggested a “device problem” was associated with a patient death.  The relevant content is highlighted in the image below.

 

 

Source

 

Questions every shareholder should be asking:

 

  • - According to this FDA Report, the patient death involved a device problem termed “failure to deploy.” We understand that “failure to deploy” refers to the failure of the Omnipod to deploy its needle which is designed to be inserted into the patient to deliver insulin. As such this could have been a contributing or the sole factor in the patient’s death. We note that the remainder of the FDA Report seems to contradict this statement entirely and seems to blame the patient rather than the device. So what is the truth? It is not clear in this FDA Report what actually happened.
  • - Why did PODD determine it did not need to disclose this patient death within its filings with the SEC?

 

5. 35 Additional Patient Deaths Possibly Tied to Omnipod

 

We reviewed every Omnipod patient death that has been reported to the FDA and included within the MAUDE database through October 31, 2016 (reported as of November 6, 2016). We paid particular attention to the “event description” for each patient death to determine (1) if a third party had determined the cause of the death of the patient and (2) if the patient death possibly related to the use of the Omnipod. It is clear to us that PODD does not know or does not wish to disclose the cause of the patient death in many cases. A total of 43% of the reports we reviewed provided clear evidence that either (1) PODD did not obtain a specific cause of death from a third party or (2) perhaps they have decided not to disclose the cause of death to the FDA. We further concluded that 89% of the reports we reviewed showed no evidence that the patient death was not tied to the use of the Omnipod.

 

Various questions arise:

 

  • - Why have the needle mechanism failures continued for the last 5 years and why can’t PODD resolve this defect?
  • - Why have the PDM failures continued for several years now and why can’t PODD resolve this defect?

 

We are providing a few examples of the commentary included in some of these other FDA Reports to display the questionable circumstances associated with many of these deaths and PODD’s apparent lack of follow-up to obtain a cause of death.

 

2149043 “He was missing for one week before being found in a lake near his home. Though the cause of his passing was not conclusive at the time of the report, it was due to "either hypoglycemia or hyperglycemia. “The customer had been using the Omnipod system at the time of the event.”

 

2287936 “The medical examiner’s office called on (B)(6) 2011 to report that a customer was found deceased in his home. He was found wearing a POD and a Dexcom CGM.”

 

4577978 “The police was then called and upon their arrival at his house he was found dead in a chair in the living room. The POD was found beeping; it was teared off the body and laid next to the corpse.”

 

5698742 “A medical examiner called to report the death of a patient wearing the Omnipod. The cause of the death was identified as hypertensive heart disease. The medical examiner requested the POD be evaluated to rile out a malfunction of the device.”

 

5848241 “The patient’s wife reported that she woke up and noticed that her husband was not breathing so she called 911. Upon their arrival they told her that he had passed away before they got there. She also reported the night before he was sweating really badly so she checked his blood glucose and it read 145 MG/DL. She stated that she wanted to take him to the doctor but he told her “no” and that he was fine. There was no report of specific device malfunction however, we cannot rule out any allegation of device involvement at this time. Pending further investigation.”

 

- What is the latest on these patient deaths?

- Were they device related?

- It appears to us that although “updates” were promised that once a patient death occurs and if an FDA Report is filed that no follow-up is generally provided to the FDA. Investors and patients are routinely kept in the dark about Omnipod patient deaths. Further, why would a medical device manufacturer such as PODD deserve a premium valuation with these questions being unanswered?

 

6.     FDA underreporting – this data infers actual Omnipod patient deaths are well in excess of 44

 

The data in the patient death chart included in Section I represents all Omnipod patient deaths reported to the FDA as of November 6, 2016. However, the FDA, a former FDA commissioner and a Harvard Medical School professor stated that actual adverse events, including patient deaths, are under-reported by a factor of 100, 20 or 10 (“FDA Under-reporting Factor”). Therefore, this chart should not be considered a complete list of all patient deaths involving the Omnipod and should only be considered to be a sample of Omnipod patient deaths. As seen in the chart we developed below, actual Omnipod patient deaths could be as low as 440 and as high as 4,400 if we rely on the FDA Under-reporting Factor.

 

 

V. “Life-threatening” Omnipod puts 28,000 children at risk every day

 

On November 3, 2016, PODD’s President and Chief Commerical Officer, Shacey Petrovic, stated that 30% of PODD’s patient base consisted of pediatric patients (i.e. children). We considered Ms. Petrovic’s statement along with other evidence we obtained from a recent sell-side analyst report to calculate an approximate number of children who used the Omnipod as of June 30, 2016. We estimated approximately 28,002 children used the Omnipod as of June 30, 2016. See the calculation in Exhibit 2.

 

We noted an FDA Report, #3695503, that explained some alarming issues with the use of an Omnipod by a child.

 

“…a false low reading, for example the PDM reads 65 when the blood glucose is actually 165, would result in me giving my child 30 carbohydrates with no insulin. After which her blood glucose would be a very high number damaging her eyes, kidneys, veins, heart. This is damaging to every part of her body…We have also had many pod failures…I have spoken with many others having the same problems we are… I do not believe the new system was ready for being put on the market. It has many issues that need to be addressed. Everyone of these issues is life-threatening and could result in death...”

 

We reviewed a lawsuit alleging securities fraud against PODD that remains pending today. On June 1, 2016, an amended complaint was filed by the plaintiffs that included some extraordinary statements by various witnesses. One witness, a professional device trainer, stated the following:

 

“The product defect aspects of the pod were “life threatening, especially for children.”

 

Source: See Exhibit 3, Arkansas Teacher Retirement System v. Insulet, et al., 1:15-cv-12345

 

We have included excerpts from 51 separate Omnipod FDA Reports associated with children in Exhibit 4. Each of these excerpts displays the unnecessary harm these children are enduring.

 

VI. Product defects

 

1. Needle mechanism failures

 

The photo below displays the internal design of the Omnipod. The blue needle protrudes to the right side of the device in this photograph. This needle, also known as the cannula, has been at the center of PODD’s problems with adverse events, patient deaths and ongoing daily risks to children, among others, since 2011. A total of 6,223 FDA Reports reference the Omnipod “needle” or “cannula” thus far. The FDA Reports are increasing rather than decreasing upon management’s efforts to correct the product defect. We don’t believe the needle mechanism failures have been resolved in the last 5 years that PODD has been aware of it and we see no reason why an investor should expect PODD can resolve it in the next 5 years.

 

 

Source: Instagram user “Pearlsa”

 

The FDA Reports included details about the Cannula failing in a number of ways, as outlined below:

 

1. Failing to deploy (Needle/cannula remains inside the Omnipod)

2. Failing to insert itself into the body as designed

3. Failing to remain inserted within the patient’s body

4. Becoming bent and therefore unable to deliver insulin into the patient’s body

5. Becoming kinked (Cannula is somehow misshapen into a sharp twist or curve) and therefore unable to deliver insulin into the patient’s body

6. Failing to retract itself back into the Omnipod device

 

A visual example of Omnipod cannula (i.e. blue needle) failures due to bending and kinking:

 

 

Source: Instagram user “psychoglycemic_t1dia_beat_this”

 

Additional evidence of needle failures is provided in Exhibit 5.

 

A few excerpts from the FDA Reports involving children and the needle mechanism failures are included below. More complete excerpts and links to the source of each excerpt are included in Exhibit 4. Remember, each of these excerpts, many of which represent notes written up by PODD employees, refer to the patients as “customers” but they actually appear to be children.

 

3760958 “The customer's parent reported on (b)(6) their (b)(6) autistic son was hospitalized…he was vomiting so they called his doctor who advised them to take him to the emergency room…The pod was removed, they then noticed the cannula was folded over and it was totally dried…”

 

3603244 “Many of the failures occurred in less than 48 hours of use, with some occurring after as little as three hours of use. Approx. 76 of the pods have worked normally, resulting in a 28% failure rate (29/105 total pods to date).”

 

4189290 … The customer's mother reported that the needle deployed 10 minutes after it was supposed to.”

 

5207721 “Our son has an Omnipod insulin pump. He has had 3 pods that failed to deploy the needle and insert, but when deactivated and taken off and set down with a little jolt all three deployed after removal…”

 

4838212 “…ever since Omnipod moved to the smaller insulin pod extra insulin has been being released from the pod during flights. I was unaware this was happening. my doctor at the time was also unaware. I have now resorted to literally removing the Omnipod on flights…I am so afraid that a child or someone who is unaware of the issue will go on a flight and have a very serious hypoglycemic event.”

 

2. PDM providing inaccurate blood glucose readings

 

4055921 “…for comparative purposes, if the battery on the Medtronic pump dies, it has memory and retains all previous information including bolus history…it will continuously alarm. Thus the pod has no connection with the PDM knowing which pod is active at the time…leads me to question the safety because it seems like the PDM has no memory of the "messages" or signals it's sending to the pod and how much insulin the pod has delivered. It just loses communication with the pod that is on the child's body…they noted that the PDM is supposed to be able to work within 5 feet of the pod (on the body); however, this one barely worked when it was within even 5 inches of the pod…(by this time I have no faith whatsoever that my child is getting insulin.)…even if it was delivering basal insulin, the pod was not able to deliver insulin boluses which keep a child alive when they eat any food with carbohydrates.”

 

5134737 “The patient's mother reported her daughter had to go to the emergency room and that she had been in two comas as results. The doctor believe that there is something wrong with the PDM as the patient's blood glucose keep going from low to high…”

 

4527412 “The patient's mother reported while sitting in the back seat of the car her daughter's blood glucose result was 60 mg/dl and that she was having a seizure so she was rushed to the hospital in an ambulance. At the hospital a BG meter comparison was performed. Her PDM read 223 mg/dl vs 481 mg/dl for the hospital's meter. She stayed in the hospital for a week before being released…”

 

VII. PODD’s FDA adverse events are rising, the last time an analyst brought these up PODD’ stock dropped 4.5%

 

The chart below displays the continued increase in adverse events that users of the Omnipod are encountering. The last time a PODD analyst brought this topic up PODD’s stock dropped 4.5%. We note that adverse events were much lower than they are nowadays.

 

 

Source: FDA Maude Database, figures provided represent all reports relating to adverse events that occurred in a specific month.

 

VIII. Regulatory risk in PODD shares is “high” if not “sky-high” – absolutely appalling to us that analysts did not ask PODD management for an update on the FDA investigation during Q2, Q3 earnings calls

 

On June 11, 2015, Raj Denhoy, an analyst at Jefferies, stated:

 

"The FDA warning letter announced today doesn’t appear material but the observations behind the letter, namely manufacturing and quality deficiencies, provide a window into the issues that have hammered the company’s recent results. We believe this issue will ultimately prove temporary and rate shares Buy."

 

It is now 17 months later. It is safe to say Mr. Denhoy’s view was quite far off. Since his statement, PODD has issued 4 recalls, the FDA has spent almost a full month inspecting PODD’s headquarters on different occasions – that we know of, and as recently as July 29, 2016, PODD confirmed that the FDA investigation into its needle mechanism failure has not been closed.

 

However, during this same time period, the market seems to have ignored the regulatory risk in PODD stock and perhaps accepted Mr. Denhoy’s view. This is inexplicable and can not be expected to continue. Simply put, an FDA investigation into any company’s products, namely a company that has just one project such as PODD, is a serious risk. Yet during PODD’s earnings calls on August 3, 2016 and November 3, 2016, respectively, the analysts covering PODD did not ask whether the FDA investigation was closed or not. This is appalling to us. There is no doubt in our minds that the FDA investigation which has now been open for 20 months (i.e. Since March 2015) is serious and perhaps “company threatening.” We can’t fathom why the analysts did not have this topic at the top of their list – though we acknowledge they don’t get paid to find negative information on the companies they cover. They also did not ask about Johnson & Johnson’s (“JNJ”) new insulin pump as well – as we explain further below in this report.

 

We have reviewed all 4 of PODD’s FDA recalls since July 2015 and 8,236 FDA Reports submitted to MAUDE by PODD and others involving the Omnipod. Our review of the FDA Reports noted various ways in which the needle, also referred to as the Cannula, could fail. The first FDA Report involving a needle mechanism failure involved an event that occurred on July 11, 2011. Including that initial report, we have identified 6,223 additional FDA Reports that referenced “needle” or “cannula” failures. Therefore, the needle mechanism failure is the most common adverse event, 75.6% (i.e. 6,223/8,236) experienced by PODD’s patients. It is clearly the most important issue PODD faces. The most recent FDA Report involving the cannula relates to an incident that occurred on October 4, 2016. The FDA Report was filed with the FDA on October 31, 2016. FDA Reports for PODD appear to be generally submitted approximately 30 days after the event date. FDA Reports since October 31, 2016 do not appear available yet in the MAUDE database (as of November 11, 2016). We believe this data we have collected represents clear and compelling evidence that the Omnipod needle mechanism failures have continued over a 5+ year time span.

 

Below is a chart we developed to visualize the regulatory timeline associated with the needle mechanism failure. We have noted the following specific dates as key dates within this timeline.

 

A.   March 11-27, 2015 – FDA surprise field visit at PODD’s headquarters in Billerica, MA “resulted in four inspectional observations”

B.    June 5, 2015 – FDA warning letter

C.    July 13, 2015 – FDA Class 1 recall (risk of death)

D.   July 13, 2015 – FDA Class 1 recall (risk of death)

E.    November 12, 2015 – FDA Class 1 expanded recall (risk of death)

F.    November 12, 2015 – FDA Class 1 expanded recall (risk of death)

G.   November 30, 2015 – December 12, 2015 – FDA surprise field visit at PODD’s headquarters in Billerica, MA “also resulted in four inspectional observations”

H.   April 26, 2016 – FDA 510(K) approval of needle mechanism design modification

I.      April 28, 2016 – on or before this date PODD requested FDA provide “closure” on the FDA investigation

J.     July 29, 2016 – PODD confirms to SEC that FDA has still not closed the FDA investigation

K.   August 3, 2016 – PODD’s CEO Mr. Sullivan spoke of an expected additional FDA inspection but gave no timeline "in of time for the FDA inspection of the facility as well as the quality system"

 

 

 

 

The lack of discussion of the status of the FDA investigation is yet another example of lack of followup and lack of transparency by PODD management. On the April 28, 2016 conference call, Mr. Sullivan explains that PODD completed all activities related to the recall. Which recall is he referring to? We also question whether this is misleading or not as the adverse events related to the needle mechanism failures (for which the recalls were issued) have continued and even increased since he made this statement in April 2016.

 

“During the first quarter, we made solid progress in resolving the quality and regulatory issues we encountered in the second half of 2015. We completed all activities related to the recall and Field Safety Notification, and we requested closure from the FDA. Our new QA and R18 did a great job in resolving these issues effectively. Our operations team also made great progress in improving the efficiency and effectiveness of our supply chain and manufacturing operations.”

 

In his statement on April 28, 2016, Mr. Sullivan explains that PODD “requested closure from the FDA.” However, a letter from Insulet to the SEC dated July 29, 2016 confirmed PODD still had not received “closure from the FDA.

 

 

It is now 20 months since the FDA investigation began in March 2105 and at least 6 months since PODD requested closure from the FDA. Why hasn’t the FDA granted PODD closure? Has PODD fully informed the public about their current status with their regulator, the FDA? This leads us to believe (1) that the issues the FDA is investigating are serious and have not been resolved by PODD, (2) PODD management not be providing a fully transparent view of the FDA investigation to its shareholders and (3) PODD’s regulatory risk is “high” – if not “sky high.”

 

When we reviewed PODD’s August 3, 2016 earnings call transcript we came across an interesting statement Mr. Sullivan made as seen below.

 

 

We contacted PODD’s investor relations team on November 11, 2016 to obtain clarity on this issue. We were told the FDA inspection Mr. Sullivan is referring to in the above quote is “normal” and “recurring” but PODD has been given no timetable for the next FDA inspection. We find it hard to believe that the FDA has “closed the book” on PODD given the recent regulatory history and increasing adverse event reports.

 

The amount of FDA activity associated with PODD thus far has been significant. The FDA investigation opened in March 2015 does not appear to have been closed as of the date of this report. We see all of these factors as evidence that PODD stock should be priced at a significant discount from its current price due to the “high” and perhaps “sky high” regulatory risk associated with its sole product, the Omnipod.

 

Several questions arise:

 

  • - Have any FDA inspections occurred in 2016 thus far?
  • - If so, what was the result of these FDA inspections?
  • - Are any FDA inspections expected between now and yearend?
  • - Why hasn’t the FDA closed their investigation?
  • - Should investors be concerned what the FDA’s next step will be given the lack of progress PODD has made (i.e. adverse events involving the needle mechanism failures are continuing) with regard to resolving needle mechanism failures?
  • - What happens if the FDA pulls the Omnipod from the market?
  • - Could the FDA pull the Omnipod from the pediatric market?

 

IX. Competition: PODD innovation at frog’s pace, Medtronic leaped ahead with the 670G and both PODD and analysts avoid discussion of JNJ’s new patch product

 

PODD is developing an artificial pancreas device that management currently expects to launch in “late 2018, 2019.” That is three years away and two years late in order to compete with two new competitive insulin pumps that should both begin impacting PODD’s business prospects in late 2016. Needless to say, PODD shows no sign of attempting to lead innovation within their sector.

 

1. Medtronic

 

In September 2016, Medtronic, PLC (“MDT”) further solidified its leadership position in the diabetes field when the FDA approved the 670G insulin pump. Recently, PODD’s stock came under pressure recently due to its competitor Tandem Diabetes Care, Inc. (“TNDM”). TNDM reported poor results on November 1, 2016 and admitted their business was feeling competitive pressure from MDT. PODD’s stock reacted to this news and dropped sharply but then rebounded after its November 3, 2016 earnings call, when PODD management, specifically Ms. Petrovic, suggested that business was not being impacted by the pending launch of the 670G insulin pump.  It was suggested that this was because of PODD’s focus on the pediatric patient base – which we understand to represent 30% of PODD’s patient base. This explanation perhaps covers 30% of the patient base (i.e. children) but does not explain PODD’s competitive landscape with regard to the other 70% of their patient base. We believe management was simply unwilling to admit the 670G was impacting the business. We expect this issue will come up again in future calls and investor interactions. We don’t expect the “pediatric focus” to continue to be an acceptable response to this question. We expect the 670G will be competitive with 70% of PODD’s patient base and Q4 2016 will be when PODD finally admits the real impact the 670G is or will have on PODD. As a result, we see PODD shares getting “Tandemed” soon on the issues we outline in this report or at the latest when PODD reports its 2016 annual results.

 

We believe the image of the 670G below provides all the investor needs to know when they consider MDT’s competitive position as compared to PODD. The image depicts a device that does utilize a tube (tubeless design is considered the Omnipod’s key selling point) but it is hardly a dramatic or more cumbersome device than the Omnipod. The image below is of the MDT 670G. Is the tube really a significant enough drawback of MDT and other devices, i.e. the tube that connects the infusion site to the insulin pump, to warrant choosing the Omnipod over the Minimed?

 

 

 

2.    Johnson & Johnson

 

During PODD’s November 3, 2016 earnings call, JNJ’s highly anticipated insulin pump, the OneTouch Via, was not brought up by either PODD or its analysts. The OneTouch Via is a thin 3-day “meal-time” insulin patch.

Source

 

For years now PODD has faced off with MDT and has gained little marketshare, if any, from MDT. If this article is correct, JNJ will launch the OneTouch Via in 2016 and PODD will then be facing not one but two international medtech leaders with an Omnipod device that has at least two serious long-term unresolved product defects associated with it, may be causing or partially causing patient deaths, and is at risk of the FDA pulling the device from the market or perhaps the pedriatic segment – which represents 30% of PODD’s patientbase.

 

Lastly, we have seen no evidence of innovation from PODD since the second generation Omnipod was cleared by the FDA in December 2012. We found evidence that as of June 2016 PODD’s internal research and development team is down to a “skeleton staff.” We question whether the development of the artificial pancreas is a priority for PODD. We suggest management clarify who is developing their new product. Is it all being outsourced? Is it really feasible to do that and still be successful? Insulet is/was seen as an innovation leader in this space. If this development is being outsourced, who are the innovators that have been hired?

 

X. Fraud allegations against previous management, signs current management has not changed the culture at PODD

 

The currently pending securities fraud lawsuit includes some serious claims and evidence against prior management of PODD. This lawsuit, Arkansas Teacher Retirement System v. Insulet, et al., 1:15-cv-12345, includes the following allegations, which are also provided in Exhibit 5.

 

“By the second and third quarters of 2012, Insulet released product that it knew had an outgoing quality level of as low as 68%. Such product would include both “Severity-A” failures such as the needle mechanism failure and the leaking pod problems…”

 

“In sum, the accusation that we had needle firing issues is absolutely true.”

 

“The Omnipod Eros suffered from a software defect that caused “unnecessary alarms for occlusion, which indicated that the pump was occluded when in fact it was not…nonetheless, despite known high defect rates, in the end Insulet’s decision was always made to ship the product because getting product shipments out the door was critical to Insulet’s survival.”

 

“One Insulet employee that she knew actually stopped using the Eros altogether because they did not trust the product.”

 

Mr. Sullivan was hired as the CEO of PODD on September 16, 2014. The following comments by current and former employees were made in the past two years since he was hired. It seems the culture with Mr. Sullivan at the helm may not be much different than when Mr. Desisto, PODD previous CEO, was at the helm.

 

1. Product failure and adverse event cover-up allegations

 

Jan 21, 2015: A former employee stated “The product has a 5% out-of-box failure rate and their solution is to send a new box to anyone who complains, cover up the complaint…the product is made in China so all defects can be handled locally without "Federal" knowledge. Distribute the defects evenly so there's an average 5% failure rate and nobody's the wiser. Play along and you'll get a nice bonus. Don't play and get "laid off…the senior management is either playing the game or being paid to keep quiet.

 

One FDA Report we reviewed referenced this “adverse event cover-up scheme” as follows:

 

“Insulet's almost disinterested response is a reason to doubt that they will diagnose the cause of these malfunctions. Their focus is "how soon would you like to receive replacement pots?" despite it being clear that replacement pods are a bad idea now.”

 

2. Allegations of forced cooperation of employees in cover-up – cover up of what?

 

May 10, 2016: A current employee stated “Middle management hides everything.”

 

May 2, 2016: A current employee stated “…brought people over who they know they can trust to fall in line and not question anything and for CYA. No morals; no values;…EVERYBODY is afraid to speak up even as they see the iceberg ahead. No diversity (especially absent is cognitive diversity). If you speak up or question, you're gone.

 

We also reference our notes above about FDA closure not being obtained – apparently, and PODD’s regulatory status not being communicated to shareholders.

 

3. Refusal to respond to the recent market discussion about cyber-security breaches of medical devices

On October 4, 2016, JNJ confirmed that its insulin pumps were vunerable to cyber hacking. This is not a complex topic. These devices are either designed to protect against cyber hacking or they are not. We believe PODD knows the answer to this question but has refused to inform its patients and the public due to the potential negative impact this news could have on its stock. Of course we are just hypothesizing but why, almost two weeks later, has PODD not responded and informed its patient of a possible cyber hacking risk – which by definition would be life-threatening for its patients?

 

XI. Ticking Time-bomb

 

We view PODD as a ticking time-bomb of a stock. Catalysts include but are not limited to the following:

 

- If a patient death linked to the Omnipod is disclosed (by PODD or a third party) to the public

- If a child dies or even almost dies as a result of the Omnipod

- PODD admitting it is feeling the competitive pressure of Medtronic releasing its 670G artificial pancreas device

- PODD admitting it is feeling the competitive pressure of J&J releasing the OneTouch Via insulin pump or any of the other 7 AP competitors we identified

- If the FDA pulls the product from the market when the FDA completes its next surprise inspection of PODD’s office

- If the FDA recognizes the harm the Omnipod is causing to children and revokes PODD’s ability to accept patients under 14 years of age – which represents 30% of PODD’s patient base

- If adverse events related to the needle mechanism failure continue to rise

- If adverse events related to PDM failures product defects rise

- If patient deaths rise?

- If PODD fails to keep up with the market and is unable to develop an artificial pancreas on schedule by 2019

- If PODD’s AP is based to some extent on PODD’s Omnipod platform, which continues to experience ongoing failures, what makes PODD believe its AP product will not exhibit the same failures?

 

We see total downside risk in PODD shares of 59% and a target price of $15. Our valuation model is as follows.

 

 

Exhibit 1

 

 

Exhibit 2

 

 

* We obtained a copy of a BTIG August 3, 2016 research report that stated PODD’s U.S. and International “ending installed base” for June 2016 totaled 62,201 and 31,140 respectively. Therefore, the total “ending installed base” for June 2016 was 93,341 patients. We have presumed BTIG utilizes accurate financial and patient information provided by PODD management.

 

Exhibit 3

 

 

Exhibit 4

 

3695503 Since we switched to the new omnipod system with smaller pods, we have had many issues. the most recent being recalled test strips in conjunction with the omnipod personal diabetes manager (pdm). the strips which were recalled still worked properly with the freestyle freedom meter, meaning the issue (blood glucose reading showing much lower than what was accurate) was the pdm and the strips being used together. a lower blood glucose reading results in more carbohydrates and less insulin or no insulin being given. a false low reading, for example the pdm reads 65 when the blood glucose is actually 165, would result in me giving my child 30 carbohydrates with no insulin. after which her blood glucose would be a very high number damaging her eyes, kidneys, veins, heart. I have received the replacement strips from Abbott and still the issue continues. a false low reading actually results in actions being taken that produce a higher a1c. proof of which is my child's a1c raising from 9.4 to 10.4 in a very short period of time. this is damaging to every part of her body. we have also had many pod failures. we have had the pod fail during a bolus. the pdm read pod failure no insulin delivered. the insulin on board (iob) was 0. we changed the pod and delivered the insulin again. after the delivery was complete, the iod showed .05 less then double the amount of insulin which should be on board. meaning if 1u was supposed to be on board, there was actually 1.95u on board. this has happened more than once. another pod failure was during insertion of the cannula. we were applying a new pod when the needle didn't insert. we deactivated the pod and started the process of removing it when the needle suddenly inserted leaving a bruised bloody spot about the size of a nickle. other pod failures include errors during basal delivery and errors while simply setting down. I have spoken with our representative about these issues and he stated that I was priming the pod incorrectly. the representative said the pod needs to be touching the right side of the pdm to correctly prime. the users manual states the pod and pdm need to be touching but not on a specific side or area. I usually set the pod directly on top of the pdm while priming, which means they are touching on the right side. since talking to the representative, I have moved the pod to right side of the pdm and still the issues continue. I have spoken with many others having the same problems we are. some have even had multiple new pdm sent to them and still the issues remain. my daughter is (b)(6) old. she is not capable of expressing when her blood sugars are high or low. she does not understand having to eat an extra 45 carbohydrates (immediately after eating 45 for dinner) because her pdm has dosed her twice. our insurance will only allow us to get an insulin pump every five years. we cannot switch pumps at the moment. we have switched meters and are using the accu-check nano and manually entering blood glucose numbers into the pdm. this is very frustrating as it creates an opportunity for human error, requires more equipment being carried everywhere we go, and eliminates one of the reasons for us choosing the omnipod to begin with (built in meter). i do not believe the new system was ready for being put on the market. it has many issues that need to be addressed. everyone of these issues is life-threatening and could result in death.

 

3800200 “The customer's mother reported that the pod was activated at 10:44 am on (b)(6) 2014. the customer's blood glucose was 400 mg/dl, and the customer had just eaten 50 grams of carbohydrates, so he bolused 17 units of insulin. at 3:30 pm, the customer has low blood glucose levels and had a seizure. he fell over and was unconscious. he was taken to the er by ambulance. the customer was hospitalized for 48 hours. the doctor was having difficulty bringing the customer's blood glucose level up out of the 30's-40's (mg/dl), so he removed the pod. the customer was treated with iv glucose. he also suffered injuries during his fall and obtained a cracked occiput, 2 small brain contusions, and a small epidural hematoma. the customer has no memory of the event.

 

3603244 “My (b)(6) year old son has type 1 diabetes, and has used the Insulet Omnipod insulin pump to manage his diabetes since (b)(6) 2009. In early 2013, Insulet announced approval of new, smaller Omnipod system. In early July 2013, we transitioned my son to the new system. Since that time, we have experienced a very high rate of pump failures compared to the previous Omnipod. Specifically, the Omnipod has alarmed and deactivated on 29 separate occasions between (b)(6) 2013, and (b)(6) 2014. Many of the failures occurred in less than 48 hours of use, with some occurring after as little as three hours of use. Approx. 76 of the pods have worked normally, resulting in a 28% failure rate (29/105 total pods to date). Eighteen (18) of the 29 failures have occurred in (b)(6) 2013 and (b)(6) 2014 alone. We have not been able to determine a consistent pattern for when the pods fail. The failures have been during delivery of bolus insulin, near the end of an extended insulin bolus, and during times of regular basal insulin delivery. The failed pods have also been on various locations of my son's body (arms, legs, abdomen), and don't seem to exhibit a consistent pattern with that either. My son is rather lean, but has had generally the same build over the last five years of using the Omnipod. Insulet has been very accommodating in replacing the failed pods and having us send the malfunctioning pods back to them for analysis, but the problem seems to be getting worse. My son has not had any adverse health effects from these failed Omnipods. However, the failures are adding unwelcome disruption to his school and home life. In addition, the failed pods are resulting in the disposal of the Insulin used to fill the pods. I estimate that we have disposed of approximately 50 units of insulin per pod, or 1450 units total. This waste is costing my insurance company thousands of dollars. If other Omnipod users are having similar problems, the resulting financial loss is troubling. The (b)(4) failed pods have come from lot numbers 40418 (10), 40563 (7), 40709 (1), 40718 (5), 40719 (2), 40737 (2), 40785 (1), and 40805 (1). I do not have the "sequence numbers" from each failed Omnipod, but all failures have been reported to the company and contain that info.”

 

3587704 “The patient's mother reported on (b)(6) 2013 her daughter activated a new pod. She was throwing up for a total of 6 hours, so she called the doctor who advised her to go to the hospital…She drove her daughter to the hospital and it was about an hour away. Upon arrival, she was admitted for mild diabetic ketoacidosis.”

 

3609084 “An Insulet clinical services manager reported that the pt was at school when he felt like he was being poked at the infusion site and upon inspection he noticed the cannula was not inserted into the infusion site. He did not tell the school nurse or call his mother and he continued to wear the pod. When he returned home from school his blood glucose was extremely high so his parent gave him multiple bolus correction (exact bg level and insulin dosage was not provided) with no improvement to his bg levels. He was vomiting so they checked for ketones and they were present. The parent called his physician who advises them to take him to the emergency room. At the er he was diagnosed for diabetic ketoacidosis.”

 

3644811 the customer's mother reported on (b)(6) 2013 her daughter's blood glucose reached 444 mg/dl less than 3 hours after the pod was activated. the pod was deactivated and she noticed the needle did not deploy the cannula all the way into the infusion site. she also stated the pod site was completely wet.

 

3795289 the customer's mother reported that had to remove the pod due to the customer's high blood sugar. the pdm read high (>500 mg/dl). the customer's mother stated that when pod was removed, it was noticed that the cannula never fully deployed. the pod was worn between 2-3 hours.

 

3640781 the customer's mother reported that had to remove the pod due to the customer's high blood sugar. the pdm read high (>500 mg/dl). the customer's mother stated that when pod was removed, it was noticed that the cannula never fully deployed. the pod was worn between 2-3 hours.

 

3732958 the pt's mother reported on (b)(6) 2014 her son was having a seizure and was convulsing so she called 911. upon the emergency medical technician's arrival he was found to be unresponsive so they checked his blood glucose it was reading 24 mg/dl. they treated hi with a shot of glucagon and he became responsive. she also stated she gave him 12 juice boxes and a sandwich. he did not go to the hospital.

 

3674359 “The customer's mother reported that the customer was hospitalized with diabetic ketoacidosis (dka) on (b)(6) 2014. The customer was vomiting and had low blood pressure. The customer's mother also reported that the customer had swelling on parts of her face and body…”

 

3674370 The patient's mother report on (b)(6) 2014 her daughter's blood glucose, carbohydrate intake and insulin history is as follows: (b)(6). Her daughter was lying on the floor shaking so she called 911. At 10:20 pm 23 grams (apple juice box). from 10:27pm to 10:55pm her bg was reading between 3.1 (56 mg/dl) to 3.9 mmol/l (70 mg/dl). at 11:29pm the paramedics arrived her bg was reading 5.6 mmol/l (101 mg/dl). she was taken to the emergency room and they placed her on an intravenous saline drip to prevent dehydration. she stayed at the emergency room for about 5.5 hours and at 1:59 am her bg result were 17.1 mmol/l (308 mg/dl).

 

3784515 “She was taken to the emergency room. upon arrival the doctor advised to change the pod immediately as they suspected there was something wrong with the pod. the pt's father didn't notice any unusual with the cannula or the pod and the doctor confirmed that the cannula was inserted correctly into the infusion site. she was treated with a manual injection (exact dosage was not provided) and at 9:54 pm her bg was reading 10.8 mmol/l (194 mg/dl). she was at the er for about 4-5 hours before being released from the hosp.”

 

3760958 “The customer's parent reported on (b)(6) their (b)(6) autistic son was hospitalized and his blood glucose, carbohydrate intake and insulin history is as follows. At 11:00 he was vomiting so they called his doctor who advised them to take him to the emergency room. At 13:00 he was hospitalized in the intensive care unit and was placed on an intravenous therapy of insulin. The pod was removed, they then noticed the cannula was folded over and it was totally dried. The next morning (b)(6) his bg was reading 119 mg/dl and the hospital staff accidently disconnected the iv of insulin and the left the iv of glucose on instead. This causes his bg to rise again and he later was diagnosed with diabetic ketoacidosis. They placed him back on insulin intravenously and at 16:00 he was released from the hospital.”

 

3763359 The patient's mother reported on (b)(6) 2014 10:44 pm her daughter activated a new pod. at 2:30 pm, she was throwing up and they decided to take her to the hospital. upon arrival, she was placed on an intravenous therapy and she was given 5mg of zofen. at 9:22pm, the pod was deactivated and there was no cannula coming out of the pod. the cannula looks as if it had never deployed into the infusion site.

 

3818024 The insulin delivery was noticeably different than another fda approved insulin delivery system. we have seen what we believe are two problems with the omnipod system on a somewhat regular basis. when we first attach and start a new pump, our daughter will go through a period of 4-8 hours where her blood sugar is high. later, near the end of the 2-3 day life of a pump, we will see the same behavior again. she will have consistently high blood sugar levels that just do not seem to respond to insulin in the same way that they did in the midlife (12-48 hours) of the pump. we have performed an unofficial experiment that backs up our claim with some data. we used our previous insulin delivery system, a novolog insulin pen, to deliver 5 units into a cap that covers the needle that works with that pen. we then took an omnipod pod which we felt was not working near the end of its life (48-72 hours), which we had detached from our daughter without deactivating, and had it deliver 5 units into an identical cap. we put the two caps side by side and compared the levels. we did this test on two different occasions and each time the omnipod system delivered noticeably less insulin. this is consistent with our belief that the omnipod system delivers inconsistent amounts of insulin over its approved 72 hours of use. we have included copies of the pictures we have taken. frequent high and subsequent low blood sugar levels.

 

4055921 medical device safety issues - insulet omnipod insulin pump from (b)(6) (anonymity preferred with the company at this time please, if possible. i am willing to answer any questions.) weekdays: (b)(6). i am significantly concerned about the safety of the insulet company's omnipod insulin pump for managing blood sugars and insulin delivery for people with type 1 diabetes. i know that many people use this system without issues or with limited issues and i've heard of many other people who have had similar problems. (some of my communications have taken place with other families with diabetes as well as using the diabetes online community.) i would like to report the continuous problems and safety concerns that my (b)(6) year old child has had with this system. my child has used the "new version" of this system since (b)(6) 2013. i'm going to number my points and include "subject" topics on each to hopefully make the information flow easily. device- the system consists of a "pdm'' (personal diabetes manager, which also functions as the blood glucose meter) and maintains all settings for the insulin delivery including bolusing and basal rates. excerpt from their website on how it's supposed to work: (b)(4) "the pod holds and delivers the insulin. the pdm (personal diabetes manager) wirelessly programs your personalized insulin delivery, calculates suggested doses and insulin on board, and has a convenient, built-in freestyle blood glucose meter. " pod failures -back in (b)(6) 2014, a few months after we first received the system, there was a week where there were three (3) pod failures. each time a pod fails its stops delivering insulin and stops communicating with the pdm. over the next couple of months, there were just a couple of random pod issues as well as several pods falling off (e.g. due to swimming.) several weeks went by with minimal pod issues. dead battery - pod failure - (b)(6) 2014 - today was another example of a pod failure. the pdm did not provide a battery warning but the device just died due to battery life. when we immediately added new batteries, the time and date were re-entered, then the system says the pod must be de-activated. when i called the helpline, they said the pod would continue to deliver the basal rate but they recommend the pod be deactivated. no other functions on the device (such as the blood sugar testing) would function at all - another safety issue, they also note any boluses and corrections would have to be manually calculated for the next six hours because of the pod failure. this is a huge safety issue because there is now no record of recent past boluses based on what they're saying. also, the pod was just applied yesterday so with pods costing (b)(4)/day), basically two days (or $(b)(4)) were lost plus the expense of the lost insulin. for comparative purposes, if the battery on the medtronic pump dies, it has memory and retains all previous information including bolus history. the worst part of it, is the literal trauma to the child who has to have a new pod removed (as noted, it was only one day old and it is a huge challenge to remove the pod due to the strong tape (even using various chemicals such as unisolve to remove.) there is always skin damage after the pod is removed. then applying a new pod has it's own challenges and pain for the child so having to do it even more frequently than the expected every three days is ridiculous. no child should have to endure this! pod alarm - when a pod fails the child no longer receives insulin. the device may or may not alarm. the alarm is a vicious screech that cannot consistently be turned off using the pdm, especially if a new pod has already been activated just fall off. if a new one is activated without deactivating the old one (e.g. when one pod falls off), it will continuously alarm. thus the pod has no connection with the pdm knowing which pod is active at the time. cannot press a button to acknowledge the alarm.) one would think that each pod device would have a unique (e.g. you identifier and this data would be retained in the pdm when that pod is activated. but apparently this is not how it's designed. instead you must take a needle or end of a paperclip and insert it into some unmarked and difficult to find spot on the back of the pod and insert it into the pod to silence the alarm. if this doesn't work, and often it doesn't, people have recommended placing the pod in the freezer to silence it, or use a hammer to destroy the pod so it would stop alarming. (remember this device is being used by young children.) pdm errors, pod failures and pins - in the course of three (3) days over this past (b)(6) weekend, we had six (6) different pod failures and a new thing - "pdm errors". when the first "pdm error" message occurred, i called insulet and their rep took the reference number and told me i had to remove the back battery door of the pdm (not the pod this time), then place a pin or needle or end of a paperclip into a tiny hole on the back of the pdm to "reset" the pdm machine. when this is done, it completely loses the time and date info and then cannot track past insulin on board, nor can it calculate a bolus for at least four hours. because of this loss of communication, the system automatically deactivates the pod only to have to be replaced again. this process of sticking needles, pins or paper clips into tiny obscure holes on the pod or pdm device is ridiculous and completely unsafe, especially if a child is expected to safely use this device. (we were traveling staying in a hotel room at the time and didn't have a paperclip or pin to use every time.) this also leads me to question the safety because it seems like the pdm has no memory of the "messages" or signals it's sending to the pod and how much insulin the pod has delivered. it just loses communication with the pod that is on the child's body. so we replaced the pod again and again and restarted the pdm several times. no pod-pdm communication after speaking with other people using the system (at the children with diabetes conference including reps from the insulet company), they noted that the pdm is supposed to be able to work within 5 feet of the pod (on the body); however, this one barely worked when it was within even 5 inches of the pod. after the fourth or fifth pod failure/pdm error and innumerable hours on the phone with omnipod customer service, i requested that they replace the entire pdm. the customer service rep, (b)(4), quite adamantly refused to do this because she said the pod was allegedly still delivering basal insulin (by this time i have no faith whatsoever that my child is getting insulin.) i explained the part about the pdm not communicating unless it is directly next to the pod (instead of the five foot range) then finally with frustration, she said she would send a replacement pdm by next tuesday for that issue (but not for the pdm errors.) i also asked that they replace the entire batch of pods (as these were all from one batch.) she said i would need management, approval for that and i would have to call back the following week. note: even if it was delivering basal insulin, the pod was not able to deliver insulin boluses which keep a child alive when they eat any food with carbohydrates. expense as mentioned, each pod failure and pdm error results in loss of at least the $(b)(4) pod (which only lasts for three days) as well as all of the insulin in the pod (a minimum of (b)(4) units each time.) with all of the pod failures and errors. i have lost at least entire bottle of novolog insulin which is also very expensive. they have replaced a couple of the pods but not all that have failed. customer service: i have had to spend countless hours of my valuable time dealing with the omnipod customer service reps who generally seem to have no idea what any of the data means and very limited knowledge of the product. when i ask them what the various reference numbers mean (that appear in the pdm when a pod fails), they just say, "we don't know, they don't tell us. our engineers use that information to make the product better." if the codes define a list of things that are happening with the device, why would they not have an explanation list of the various reference codes? that could serve as "teaching tool for patients so if they do consistently encounter a particular reference code, perhaps that data could be used for education, as well as improving the product when trends are identified. new pdm­ - more pod failures. we did receive the new pdm, got the settings set up late last night, then applied a new pod to my child. with the first bolus, the pod failed again in the middle of the bolus! i called insulet this morning and asked to speak with a manager. i left a message. i did hear back from someone this afternoon who seems to be a management person and she seemed concerned and wanted to help. she said she would send some replacement pods to try. (however, we will not be able to do this until my child returns from diabetes camp.) model#: not available at this moment.

 

4115529 “An email communication was received to report that on (b)(6) 2014, before going to bed, the patient's blood glucose reading was 75 mg/dl and he had not had anything to eat for dinner. On (b)(6) 2014, at 5:00 am, he woke up and took a shower. During his shower, he fainted; foam was coming out of his mouth and his nose was bleeding. His mother called for the paramedics and upon their arrival, his bg was reading 29 mg/dl. He was treated with glucose intravenously and did not have to go to the hospital.

 

4189290 “Time: 1:50 pm, blood glucose (mg/dl): 283. time: 3:00 p.m, blood glucose (mg/dl): 324. Time 3:55pm, blood glucose (mg/dl): 294 - pod deactivated. The customer's mother reported that the needle deployed 10 minutes after it was supposed to.

 

4196364 The customer's mother reported on (b)(6) 2014 her daughter's blood glucose history is as follows: time: 2:18pm, bg(mg/dl): 300, time: 11:43pm, bg(mg/dl): 383. she stated that the pod was not sticking to her skin while she was at school. she was having chest pains and trouble breathing so she took her to the emergency room.

 

4377205 The customer's mother reported that the customer was taken to the er for a second time that day. the customer had a blood glucose in the 400-500 mg/dl range and had been vomiting all day. the customer was treated for nausea and given a prescription for ondansetron. the mother treated the high bg with a manual injection of insulin.

 

4253540 My (b)(6) son received the omnipod insulin pump manufactured by insulet recently. on every third day or last day of wear, the insulin pod seemingly failed because his glucose levels increased to abnormally high levels. we informed insulet corporation of the problem and the company sent us a new omnipod replacement pdm device. however, on the first day of using the replacement omnipod pdm device on (b)(6), my son's glucose rose to 240 mg/dl on the first day, after one meal. this glucose value is atypical for him. the pod did not give any warning alarm to notify us of any insulin delivery problems. the humalog insulin that was inside of the pod was fresh and expires in 2017. my son continues to receive lantus as his basal insulin and he did not miss any lantus doses. we do not use the insulin pump or pod for his basal insulin delivery but only for his mealtime boluses. after this high glucose value, we instead gave him a traditional shot of humalog 1 unit via a pen shot and his glucose came down to a normal level or 116 mg/dl after 20 minutes.

 

4527412 “The patient's mother reported while sitting in the back seat of the car her daughter's blood glucose result was 60 mg/dl and that she was having a seizure so she was rushed to the hospital in an ambulance. At the hospital a bg meter comparison was performed. Her pdm read 223 mg/dl vs 481 mg/dl for the hospital's meter. She stayed in the hospital for a week before being released. She did not provide any further information regarding the hospitalization or her treatment.

 

4874987 The patient's mother reported that her daughter was having an attack, she was trying to hurt herself, she's going out of control and this is how she acts when her bg is high. she called 911 and upon the paramedics arrival and bg meter comparisons were performed. her pdm read 160 mg/dl vs bg in the 500's mg/dl for the paramedic's meter. they gave her a manual injection of insulin (exact dosage was not provided) and stayed with her for an hour until she was stable. she confirmed that she was using the (uncleared) freestyle lite strips.

 

4838212 Omnipod moved to a smaller insulin pod. ever since omnipod moved to the smaller insulin pod extra insulin has been being released from the pod during flights. i was unaware this was happening. my doctor at the time was also unaware. however, i was expressing my concern to a colleague who then did some research online and discovered that the nih had tested medtronic and animas insulin pumps a few years ago and proved that extra insulin is being delivered during flights. i then went to my doctor and told her about it - which she was unaware. so i saw someone else in the practice who had confirmed she knew that animas and medtronic delivered extra insulin. i travel on average 8 flights a month so this has been a big problem for me. i tried many compensating behaviors to account for this such as running temporary basals, turning off the insulin pump, eating extra food before flights and under blousing, bringing numerous supplies to treat hypoglycemia. i have also reported this numerous times to omnipod. i have now resorted to literally removing the omnipod on flights. what i have observed when removing omnipod on flights is that insulin is bubbling out of the cannula during take-off. but not at any other time of the flight. i am very insulin sensitive - only requiring around 12-18 units total in one day - therefore the extra insulin - which the nih reported could be on average (b)(6) for animas and medtronic is equivalent to eating a big meal for me. i am very, very concerned about this issue and want other who are insulin sensitive to be aware. i am so afraid that a child or someone who is unaware of the issue will go on a flight and have a very serious hypoglycemic event.

 

5057747 The patient's mother reported on (b)(6) 2015 at 10:31 her daughter activated a new pod and her blood glucose history is as follows: time: 11:51, bg (mg/dl): 199. (b)(6). time: 7:52 am, bg (mg/dl): 199. she was vomiting so she went to see her doctor and after they did some blood work they realized that her bg was reading over 500 mg/dl. she was then rushed to the emergency room where she was diagnosed with diabetic ketoacidosis. they placed her on an insulin drip. she was in a comatose state for 2 days. the pod was removed and discarded. she stay in the hospital and was released on (b)(6) 2015.

 

5128686 The customer reported that her daughter's blood glucose was at a low of 20 mg/dl and then reached > 600 mg/dl. The patient was in a coma, was treated at the hospital and eventually came out of it.

 

5134737 The patient's mother reported her daughter had to go to the emergency room and that she had been in two comas as results. The doctor believe that there is something wrong with the pdm as the patient's blood glucose keep going from low to high. Her blood glucose history is as follows:

 

5180928 The customer's mother reported that her daughter's blood glucose was reading at 238 mg/dl with an alternative meter and that the pdm meter was reading at 349 mg/dl. patent went to hospital and diagnosed with diabetic ketoacidosis. at the hospital a bg comparison was done and that the pdm was reading 100 points higher than the hospital's meter.

 

5207721 “Our son has an Omnipod insulin pump. He has had 3 pods that failed to deploy the needle and insert, but when deactivated and taken off and set down with a little jolt all three deployed after removal. First 2 pods were on (b)(6) 2015, the 3rd was (b)(6) 2015.”

 

5235214 My (b)(6) daughter, diagnosed at (b)(6) with type 1 diabetes, has been using insulet omnipod for four years. though some isolated equipment problems sporadically, the recent failures of this omnipod, resulted in high blood sugars and ketoacidosis. stress beyond belief, trouble in school, missed school, loss of sleep and inflicted illness which further increase blood sugars. additional pod changes which are extremely painful and many, many tears. ketoacidosis was treated with additional insulin which were painful boluses as well. poor kid suffered and was almost hospitalized due to these product failures. now i am advocating to obtain replacements for these pods in this lot.

 

5223373 “The mother reported that the patient had a seizure and was admitted to the hospital for hypoglycemia while wearing a pod. she was treated with glucose intravenously.”

 

5245592 It was reported by the patient's father that she has been hospitalized nine times.

 

5210435 My son has been using the omniopod system for about four weeks. during those four weeks he has experienced numerous episodes of hyperglycemia after insertion of new pods. he had to go to the emergency room and to his doctor using this period due to hyperglycemia and medical illnesses caused by his hyperglycemia.

 

5268054 The patient's mother reported that her daughter was found unconscious due to high blood glucose and that she had to be admitted into the intensive care unit for a few days.

 

5290573 Failures of insulet corporation's omnipod insulin pumps. omnipod insulin pumps have two operating components: a small disposable pump, called "pod," worn on the body of a diabetic patient, and a close-range remote controller, called the pdm, used to control the pod, via a radio signal within a range of several feet. (b)(6), living in (b)(6), had three of his omnipod insulin pods fail consecutively on (b)(6) 2015 and (b)(6) 2015, while spending time with his father, (b)(6). all three failures were similar: unexplained rise in (b)(6) blood glucose, to very high levels, starting a couple of hours after a bolus, sometimes the correction dose, is administered using the pod. the changes of (b)(6) glucose levels are observed using his continuous glucose monitor (cgm) which is verified intermittently using (b)(6) blood glucose meter in the pdm. shortly after (b)(6) has his pod replaced, his blood glucose decreases to normal levels. very recently, an additional problem was manifested: unexpectedly low blood glucose only several hours after applying and activating a new pod. these problems were observed by (b)(6) father, (b)(6), who cared for (b)(6) during that time. (b)(6) observed similar problems with (b)(6) glucose control starting at least as early as (b)(6) 2015. but (b)(6) did not suspect failures of the pods until (b)(6) 2015 and, thus, has not documented those previous suspected failures. (b)(6) does not recall observing such problems during the summer of the year 2015. observation is possible only every other weekend which (b)(6) spends with his father. (b)(6) mother, (b)(6), claims that there were no problems with the pods. but (b)(6) has told his father on (b)(6) 2015, that the school nurse and his class aide have remarked about increase number of occurrences of (b)(6) having high blood glucose and low blood glucose. (b)(6) has reported my observations, of problems with my son's glucose control, to insulet customer service on (b)(6) 2015 on the telephone and then very early in the morning on (b)(6) in writing, (b)(6). but insulet's almost disinterested response is a reason to doubt that they will diagnose the cause of these malfunctions. their focus is "how soon would you like to receive replacement pots?" despite it being clear that replacement pods are a bad idea now. reporting on telephone was very frustrating and finding a way to submit a written report to insulet via the internet has taken a little time, too. (b)(6) had to insist on reporting in writing to get help finding out how to use the submission form on their website. on (b)(6), insulet's customer-service representative has reiterated to (b)(6) that he report any future problems to insulet on telephone rather than in writing. the customer-service representative has refused to give to (b)(6) the full names of the managers who have told her to say it to (b)(6). insulet is not interested in obtaining logs from (b)(6) continuous glucose monitor and from the omnipod pdm. insulet's customer service refuse to put (b)(6) in contact with insulet's engineering team. lot #'s and serial #'s of the 3 pods subject of this report: lot #l41580, sn #(b)(4); lot #l41580, sn #(b)(4); lot # l41580, sn #(b)(4), see detailed report, in a copy of (b)(6) message to lev's endocrinologist, starting at the 7th paragraph (number "1), at http://problemsindiabetescare..blogspot.com/2015/11/urgent-safety-proble....

 

5311383 The patient's blood glucose level was over 500 mg/dl. the pod was not worn. the patient's mother stated that cannula deployed 5 minutes later after it had already been set to the side.

 

5348044 “The patient's grandmother reported that the patient was hospitalized as a result of hyperglycemia and an inflamed pancreas. the patient was also vomiting.”

 

5587804 The freestyle omnipod's failed to deliver insulin. they report that it is from pod failure, but i believe it is much more than that. i have tried contacting the manufacturer for a refund, and additional people who are supposed to call me back have failed to do so. my alc has increased, and my kidneys are showing damage from inefficient delivery of insulin. this began to happen at the end of last year, but i was guaranteed that other pods delivered insulin fine. i am proof that they don't. i have spent many precious hours trying to get the company to resolve this and my problem, but they refuse to move forward and do the right thing. i cannot afford to purchase another device until i receive a refund. i have had blood sugars 400 and even above, this is affecting my life in a very negative manner, and the device needs to be taken off the market until a solution is figured out. people like me have suffered from high blood sugars which come with terrible side effects. the device and the company need to be investigated and closed until the units no longer damage individuals health.

 

5821902 my daughter is a type 1 diabetic and uses the omnipod system. she constantly has defective pods. recently, she was in the hospital and her endocrinologist had the in-house omnipod rep come to the hospital and put a pod on her. when she checked her sugar in order to eat, the system told her the pod wasn't working, so the rep brought another pod. this past weekend, she put 200 units in her pod, went to eat and her system told her she did not have enough insulin for her meal. she began throwing up. her sugar was so high, it would not register on the meter, it just read "high." it continued to read "high" so she began giving herself injections with her novolog pen. she has a new pod but is continuing to have readings 240, 250. she celebrated her (b)(6) birthday today, so she's wanted me to put off calling the doctor because, more than likely, she'll end up back in the hospital. i've been reading reviews on the omnipod system and see that they have had recalls, warnings, lawsuits, etc. i'm not sure what to do at this point. i'm not sure what the return policy is. i still owe money on the system, but with the problems we continue to have and seems the problems are worsening, i'm strongly considering no longer using the system. i plan to discuss with the doctor in the morning and probably the company from whom we bought the omnipod system.

 

5434486 the patient's mother reported that her child had to be hospitalized for a day and a half with diabetic ketoacidosis due to the pdm not giving the correct insulin doses.

 

5548298 The patient reported high blood glucose (bg) and not feeling well. patient was retaining water and hypotensive. the patient was hospitalized (b)(6) 2016. she also noted that she has stage 4 acute kidney injury (aki).

 

5614256 Customer's mother reported recent changes in basal rate and her blood glucose level was not going down. pdm appeared to be working incorrectly. daughter was hospitalized with kidney failure and was having a shunt placed for dialysis

 

5800256 “The patient's mother reported that her daughter had to be hospitalized due to high blood glucose levels. At the hospital she was diagnosed with an enlarged kidney, heartbeat of 183, blood infection, kidney infection, and had a stent placed in her kidney. She did not provide any further information regarding the hospitalization.

 

5753587 The patient¿s father reported that his son was vomiting and that he was nearing a coma situation by the time he arrived at the emergency room. he was admitted into the intensive care unit with diabetic ketoacidosis.

 

5749303 The patient's father reported his daughter's blood glucose history is as follows: time: 5:05 am, bg (mg/dl): 95. he then noticed a pod alarm. 10 minutes later 11. she had a diabetic seizure while she was sleeping so he called for the paramedics. upon their arrival her bg was reading at 11 mg/dl (with the emt's meter) and the pdm was reading at 95 and 94 mg/dl. they used something to help bring up her bg levels. dad stated that he was not sure what the paramedics gave his daughter. she was taken to the hospital where they monitored her bg levels overnight.

 

5983649 Patient's parent reported that their child had a reaction to the adhesive (itchy, red, raised bumps) causing the patient to itch the pod off during the night. unaware that the pod was no longer attached the patient, blood glucose level rose to 479 mg/dl and patient was taken to the hospital. patient was diagnosed with dka (diabetic ketoacidosis).

 

5878187 The patient's mother reported that her daughter was admitted to the emergency room after her blood glucose (bg) levels reached 898 mg/dl. she was diagnosed with diabetic ketoacidosis and treated with an insulin drip. the pod was worn between 4 and 24 hours

 

5878200 New pod was placed on and his blood glucose level increased to 380 mg/dl. the doctor and mother both feel the pdm is having issues communicating with the pod, since the pods didn't give errors and the pods appeared normal and the insulin was fine. pdm was requested to be replaced.

 

5950680 Customer's dad reported his son had increased blood glucose levels which reached 330 mg/dl and he did not think the pod was delivering insulin accurately. when the pod was removed he said the cannula looked bent.

 

5948744 The customer's mother reported her son's blood glucose reached greater than 300 mg/dl after wearing the pod between 24 and 36 hours. she also reported that the pod fell off while sleeping and that the cannula had come out.

 

5913354 Caller advised her daughter had the omnipod inserted in her left arm and sometime last week her daughter complained of pain. upon examination of the left arm, a burn was noticed characteristic of second degree, swelling, skin erosion and crusty skin were present as well. a home nurse visited and they used a new omnipod. the skin was prepped before the omnipod was placed. on (b)(6) 2016, she took her daughter to see her physician who diagnosed cellulitis and cortisone ointment was prescribed. caller already reported to mfr about side effect and was informed that 2 percent of users suffer from side effects. she wants other users to be aware of this negative side effect.

 

Exhibit 5

 

 

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We are short shares of PODD and are long PODD puts. We may add to our short position at any time.  All information included within this report is sourced from publicly available materials.  As of the publication of this report we have not communicated with the executive management of PODD or their shareholders.

 

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Comments

FYI - there was a misread with patient #3. This article states that the PDM was giving falsely low results, Insulet blamed Abbott's strips, but the doctor checked the patient's strips with a control solution and found them in range. That is not what the FDA report says. According to the report as highlighted, the doctor checked the patient's strips and found them reading extremely low (23 mg/dL). It says that the doctor then used *another set of strips* and got in-range results. So in the case of #3 it does appear the issue was a bad lot of strips, not the Omnipod PDM.

A few points: 1. We believe the totality of our research (please read the entire report and all 51 quotes from parents and users in Exhibit 4) tells us the PDM has a product defect. We do not pin all of our comments on this one example that you are choosing to highlight. 2. You comment suggests that Insulet should be believed and we should not be believed. What is your basis for this? We trust patients and users to tell us the truth. We do not trust the management of any medical device company and suggest you should question them as well. We believe fraud in the medical device sector is rampant. This is one of the reasons we focus our attention on the sector. Do you think our research is wrong and the PDM does not have defects? We would enjoy hearing your thoughts on this. 3. We expect more clarity soon on the trusthworthiness of management.

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