The major point for this article is to discuss the conflicting information that MannKind has issued in recent public events, information that is in direct conflict with information shared on every Afrezza prescription that is filled for a patient. The nature of this conflict is critical information for the prescribing medical professionals and most assuredly important for their patients. The title of my article can be resolved only by MannKind clarifying which of their claims represent the factual data points at issue.

Al Mann was a very creative visionary where he developed MannKind (MNKD) and 16 other companies for the aerospace market and the medical industry. His most successful company was MiniMed, an insulin pump company he later sold to Medtronic. (MDT)

Of the 17 companies, he personally took two of them into the public market—MannKind and Second Sight Medical Products, Inc. (EYES). With the great success for the insulin pump creation the success of the two companies Mann turned into publicly owned companies, the Midas Touch didn’t follow the earlier accomplishment.

MannKind has spent approximately $3 billion, with Al Mann’s personal funds being the major contributor for their only product, Afrezza. And Afrezza has been a colossal failure in the marketplace. This has resulted in the stock losing about 95% of its value since Sanofi signed on in late 2014 to sell the product into the world-wide market. The current trading price would be $0.27 based on the prior 1:5 reverse split price. As for Second Sight, the story is the same, only worse—the stock closed this week at $0.89 cents, placing them in danger of being delisted from the NASDAQ.

In the nearly five years I’ve written articles about the company the internal deterioration has continued unabated. However, in recent weeks, several public statements and claims have given rise to what appears to be conflicting statements related to critical metrics that have relevance for the future of MannKind remaining a viable and operating company. With this article I plan to merely pose the issues, with no judgement as to why the purveyors of the diverging claims might have a benign or ulterior motive in generating the conflicting information. I have no monies invested in MannKind; therefore I have no vested interest in which of the conflicted items are the truth of the matter. My position is simply you can’t have two issues with different interpretation for the relevant data and not expect that one’s investment will not be eventually impacted when the truth is revealed.

My fellow contributor, Spencer Osborne, does a great job with his weekly updates on MannKind. His clearly submitted tracking data for revenues and expenses are spot-on for clarity and usefulness. However, I have several issues with his recent “Fireside Chat” article where he interviewed MannKind’s CEO. The issues relate to what appears to be a case of the interviewer allowing the person being interviewed set the agenda as for the topics. After allowing this to occur he then fails to challenge statements that were made in direct conflict with previously shared data relating to the perceived issues. In this case, with each prescription filled for Afrezza, these prescriptions come with a package insert label. Based on the fact that MannKind is now making public statements that conflict with the package insert data, investors need clarification for whether the package insert is correct or do the new public claims represent the factual data points! Logic would be that if MannKind has supporting and valid clinical data “proving” the new claims, why hasn’t MannKind submitted a corrected package insert for the medical professionals and their patients?

For those invested in the stock, I think it would be a wise decision to seek clarity as for which position on the issue is the actual case. IMO, it would be a great service if Mr.Osborne would seek out another opportunity to interview the principal players, where a definitive resolution can be arrived at —for the investors, the medical doctors, and the potential users of Afrezza

The First Data Set:

Since Sanofi first launched Afrezza into the marketplace in late January 2015, we have seen 241 weeks, or 4.63 years, of active marketing the product as of the latest weekly report shared on September 13 th, 2019. During this extremely long period for a product being available for use by patients, we have seen three officials launches and every conventional and proven method for introducing a product to the customer being utilized — with no success!

MannKind Weekly Data for NRxs First Breaking 300

5/25/2018

300 NRx

Cumulative Amount

to 9/13/2019

Report:

19,708

68 Week Average:

289

The “true believers” and investors were ecstatic when weekly new prescriptions under MannKind’s marketing reached the 300 level on the 5/25/2018 report. Apparently forgetting that Sanofi had reached the 400+ level in the short period of time they marketed the product. By using this May 2018 milestone and looking at the weekly cumulative results for the ensuing 68 weeks, or 1.3 years, we see 19,708 new prescriptions being filled. This translates into the original 300 base number for NRxs creating a weekly average of 289 NRxs. This simply means obtaining new prescriptions has decreased the weekly average over the last 68 weeks of data collecting. With new prescriptions showing flat weekly results for more than a year, the growth has apparently plateaued.

MannKind Weekly Data for Refills First Breaking 300:

8/24/2018

308

Cumulative Amount

to 9/13/2019

Report:

18,763

55 Week Average:

341

Using the same criteria of reaching 300 refills on a weekly basis, we find this event occurred with the 8/24/2018 level. Now when we consider the cumulative refill numbers for these 55-weeks, 1.05 years, the weekly total averaged 341 refills. This translates into a mere 10.7% gain, when refills should be a constant rolling 100% refill growth for such prescriptions.

MannKind Weekly Data for Revenues First Breaking $1 Million:

12/21/2018

$1.117M

Cumulative Amount

To 9/13/2019

Report:

$37.912M

37 WEEK Average:

$997,682

The “true believers” and investors when faced with the never-ending dismal weekly prescriptions data, they merely dismiss the data as having no meaning and kick the can down the road –until tomorrow! They are totally ignoring the end of the calendar year for 2019 is fast approaching where full year numbers for corporation’s profits or losses are revealed. Merely go back to the 12/21/2018 weekly report where Afrezza weekly revenues hit the magical $1.0 million mark. Now 37 weeks later, the weekly revenue cumulative number is $37.912 million, or a weekly average of $997,682.00. This simply shows that for nearly 75% of a full year, the weekly revenue number is averaging LESS than the number seen on 12/21/2018.

Now approaching five (5) calendar years, numerous marketing models, firing and hiring new sales teams, reducing drastically the states they will even attempt to market their single product, a product where it has been shown clearly that the critical data points have flattened out in growth and even regressed is a very ominous sign. Based on the ongoing business model, if they can’t sell the product in the United States, can Afrezza be sold in any other nation where cost is a major factor?

Bioavailability:

In pharmacology, bioavailability is a subcategory of absorption and is the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. When a medication is administered intravenously, its bioavailability is 100%.

MannKind—A Fireside Chat with CEO Michael Castagna

Spencer – So slowing the particles down allows for better deep lung delivery. The inhaler also has attributes which offer a very consistent and predictable dosing. If I am not mistaken, MannKind’s device will deliver 70% of the product deep within the lungs. What levels do other inhalers have, and how consistent are they?”

Mike That is also correct. We deliver approximately 70% of the inhalation powder contained in the cartridge into the lung. This is a high number for an inhaler and one that’s extraordinary, considering we are delivering milligram quantities of powder. Most inhalers in the asthma space are delivering microgram quantities and many of those can only approach around 30%. Importantly, our 70% delivery occurs consistently across all types of inhalation efforts. Many inhalers only work well when patients inhale very fast and hard. With ours, a patient can inhale comfortably and still realize a complete delivery. This is because we designed our inhaler and its delivery engine by incorporating patient factors into the process. We created anatomically correct airway models and linked them to lung simulators to study inhalation efforts and their subsequent effects on powder delivery from our inhaler. In the end, majority of patients find it easy to use the inhaler.”

Seeing the statement claiming that by slowing down the Afrezza particles this would allow better delivery to the deep lungs, is both an amazing and puzzling proclamation. I’m not an aeronautical engineer, but I have flown on at least a thousand flights. My rudimentary understand for how an airplane can lift off from a runway and proceed to a destination point revolves around generating enough ground speed(runway roll), ‘trim ’of the wings and tail, and then have the proper ‘angle of attack’ for the air flow over the wings. This all being contingent on the thrust generated by the plane’s engines. Now we find out that Afrezza’s delivery, to the desired deep lungs, is contingent on merely slowing down the particles. This being contrary to an aeronautical engineer telling you that when a plane loses thrust it turns into a brick. This appears where the new claim of delivery indicates MannKind’s engineers have proven entirely new operating principals of aerodynamics. We all could hope that MannKind doesn’t decide to move into aircraft manufacturing, but if they do, the name Titanic would be a good name for their production.

Same Issue but Different Answer in the Past:

11.2 AFREZZA Inhaler –

“The AFREZZA Inhaler is breath-powered by the patient. When the patient inhales through the device, the powder is aerosolized and delivered to the lung. The amount of AFREZZA delivered to the lung will depend on individual patient factors.”

So now we see the claim about most patients finding it easy to use the inhaler and they experience 70% of each dose being delivered to their deep lungs. Only now, and found on their prescribing label insert, we discover that the amount of Afrezza delivered to the lungs will depend on individual patient factors. I’m assuming the ability to undertake deep breathes and proper handling of the inhaler are factors in how successful each dose is delivered to the deep lungs.

Now that we have this conflict on the 70% bioavailability of Afrezza we can move to the next section of the label insert found in each prescription. This is the link for the source for the bioavailability of MannKind’s dry powder based Technosphere delivery system(12.3 Pharmacokinetics):

Carrier Particles – Clinical pharmacology studies showed that carrier particles are not metabolized and are eliminated unchanged in the urine following the lung absorption. Following oral inhalation of AFREZZA, a mean of 39% of the inhaled dose of carrier particles was distributed to the lungs and a mean of 7% of the dose was swallowed. The swallowed fraction was not absorbed from the GI tract and was eliminated unchanged in the feces.”

I have no opinion on this apparent discrepancy in this critical data point needed by prescribing medical professionals and their patients. I will merely state that my mathematic skills always found that 39% is much less than 70% when applied to the same data.

Promises About What They Are Going to Do Tomorrow is the Issue:

Spencer – “ The MannKind initiative on BluHale already has some pretty interesting attributes. Currently the device can assist in holding the inhaler properly, getting the patient to inhale properly, and even sense the dose via recognizing the color of the cartridge. This data can all be uploaded to the digital platforms with CGMs like Dexcom ( DXCM) and Free-Style Libre. In meeting with your engineering team, we discussed some future possibilities including trailing data. Can you expand on that discussion a bit and offer crossover insights to TreT? Is there an FDA approval aspect that needs to happen prior to commercialization? If so, where does that stand? How will this be marketed to consumers?

Mike – There is a lot to be worked out still in the digital space. We believe BluHale will be an important platform not just for Afrezza, but our pipeline products as well. I know you had the opportunity to meet with our engineers and I think you can see there is a lot of opportunity in the future. To accelerate this digital transformation, we decided to partner with One Drop initially because they have important components of the digital world that we think will be useful to patients such as dose tracking, coaching, ability to integrate Dexcom CGM data and eventually overlay our dosing data. We see additional applications for BluHale for our pipeline that I don’t want to disclose for competitive reasons, but we regard it as a platform technology. As for the commercial and regulatory model, we have started working on those plans and expect our stakeholders will have clarity in 2020 as the digital landscape and regulatory framework is evolving rapidly!

The issue I see with this response found in the Fireside Chat is the following:

We see additional applications for BluHale for our pipeline that I don’t want to disclose for competitive and regulatory model, we have started working on those plans and expect our stakeholders will have clarity in 2020 ..”

It appears that MannKind is now claiming they are starting work on their Bluhale product and investors should see some clarity in 2020. My issue with this claim is that eight years ago, 2011, MannKind produced a video presentation outlining their development of the same BluHale inhaler for their pipeline.

The following is a link for a YouTube presentation made by MannKind in 2011.

https://www.youtube.com/watch?v=aB_-IK3WW28

This quotation is from an article published in 2011, as a follow-up from Dr. Andrea Leone-Bay’s information shared in 2010. (Pulmonary Drug Delivery – Simplified) The complete article is found on Pages18-21, and it clearly outlines that the Bluhale inhaler was in advanced development at least nine years ago.

This configuration allows capture of inhalation data during dose administration without affecting the patient/device interface. An interactive screen receives the BluHale transmission and enables users to visualize their inhalation efforts in real time. These data facilitate device “tuning” to meet the needs of the specific patient population. When a clear and readily measured clinical bio-market is available, pharmaceutical data are used to establish a relationship, or lack thereof, between dose response and user technique. BluHale can also serve to eliminate unwanted sources of variability associated with varied inhalation technique. Taken together, using BluHale to profile patient inhalation technique helps define the design space for the pulmonary system within the intended patient population. This approach to comprehensive understanding for all aspects of the inhaled delivery helps advance the drug candidate quickly along the development timeline.”

During the assessment for mass percent emptying, patient-mimicked physiologic inhalation efforts are created using MannKind’s MIDAS (MannKind Inhalation Data Automated Simulator) and BluHale systems (Figure 3). MIDAS is a linear servo driven syringe pump with a customised algorithm for replicating patient inhalation efforts. It is used in combination with an anatomical model to replicate a patient’s upper airway (mouth and throat). BluHale is a compact, wireless pressure profiling technology used to capture and transmit data from a patient’s inhalation effort. It features a small, discreet, electro-acoustic sensor that outputs a signal calibrated to pressure.”

As it relates to this issue, again it’s my position that investors should seek answers for why it has taken a decade and they are still working on their technology platform that will be a key for their future product development efforts. A twenty-plus year-old technology in Technosphere and now what will soon be 10 years of promising a product known as BluHale, investors might want to consider what the competition is doing with their product development and related technology.

I informed my readers back in 2017 as it relates to the issues seen in the Technosphere platform. In the interim about 80 inhaled drugs have been created and approved by the FDA. These FDA approved inhaled drugs merely prove one thing about all the patents MannKind claims with their technology. MannKind’s patents haven’t kept one company from developing a viable inhaled drug and it is infringing on MannKind’s patents. This is just a list for some of the inhalers used in delivering various FDA approved drugs. Note the degree and flexibility for what these inhalers offer.

Standard of Care or Lack of Caring About Afrezza Being a SOC for Diabetics:

https://seekingalpha.com/article/4287312-mannkind-fireside-chat-ceo-mike-castagna

Mike You had the opportunity to talk with Dr. David Kendall and I think you can see he has been hard at work building out the scientific story among diabetes thought leaders, through clinical presentations at scientific conferences, upcoming publications in peer-reviewed journals and dozens of interactions with physicians across the country every month. As you may have seen, the ADA standards of care were updated in December to reflect the unique attributes of Afrezza, which are a direct result the new data we generated and published. David has been a great addition to the team and is continuing to make strides in shifting the thought process among his peers….”

Diabetes Technology as Defined by The ADA:

https://professional.diabetes.org/content-page/practice-guidelines-resources

The following link takes the reader to the ADA website where they outline the various diabetes technology they have incorporated into their Standard of Care guidelines. And in the case of MannKind’s technology is the issue of why their technology isn’t worthy of being listed by this august group of diabetes professionals.

Historically, diabetes technology has been divided into two main categories: insulin administrated by syringe, pen, or pump, and blood glucose monitoring as assessed with a meter or CGM system. More recently, diabetes technology has expanded to include hybrid devices that monitor glucose and delivery insulin, some automatically, as well as software that serves as a medical device providing diabetic self-management support.”

It appears MannKind and Dr. Kendall are now taking credit for getting the ADA to change their Standard of Care protocols based on MannKind’s data and such data being published. My issue is simply the fact that when one reads the latest SOC guidelines, some might find it strange the same professionals actually creating the SOC guidelines failed to mention MannKind’s inhaled product as being one of the technology products in their description of diabetic technology

The Most Expensive Insulin Product on The Market:

Now look at cost data as shown in this report issued on Friday, August 23 rd, 2019. Note this report is provided by MannKind’s latest partnership alliance—GoodRx!

The analysis also shows that price increases this year affected a select group of insulins: mainly long-acting insulins, those that control blood sugar throughout the day, and Afrezza, the inhaled, ultra-rapid-acting insulin made by MannKind.

Afrezza has gone up in price by 8% since the fourth quarter of last year. And manufacturers Sanofi-Aventis and Novo Nordisk both raised prices of their long-acting insulins by as much as 6% during the same period, calling into question the pledges they made to help rein in insulin prices. In 2017, Sanofi-Aventis had vowed to limit annual price increases to a rate below medical inflation (effectively 5.4%). And Novo Nordisk promised just months before to cap annual price increases to single-digit percentages.”

Price Per Insulin Unit:

Lowest to Highest Cost

Generic Insulin Lispro

$0.18 per

Unit

Afrezza Cartridge (4 Unit)

$1.11 per

Unit

Afrezza—the insulin product that cost more than 6 times the lowest cost insulin product, plus the dosing required greatly exceeds the doses of other insulin products. And why is this? If the actual bioavailability is what the label inserts state, this means 61% of each dose is never deposited in the patient’s lung for the ultimate delivery to the body. If the wastage reaches the 61% level this link shows why Afrezza a major flaw in the Technosphere system. Having our citizens flocking to Canada to purchase their insulin, then why would some think that cost will not be a factor in Brazil, or any other country where MannKind seeks marketing rights? Considering nearly all other nations of the world have government funded healthcare, why would anyone think they will be willing to fund Afrezza for their citizens? With headlines like this— Brazil’s Economy Continues Downward Towards Recession (8/12/2019), should anyone think their government is going to allocate money to purchase the most expensive insulin product on their market?

United Therapeutics PAH Products FDA Approved and Pipeline Products:

The following is list of the treprostinil based products that United Therapeutics has under their control and marketing efforts. As a capstone for the business model and strategy that United Therapeutics is using to ‘protect’ their dominance in the PAH market, this latest lawsuit details the game plan. It should be remembered the current ‘true believers’ contented that Sanofi made their deal with MannKind just to keep Afrezza from becoming a viable product in the marketplace. Is United any different than Sanofi based on the goal of this lawsuit?

Orenitram- This is a treprostinil based extended-release tablet. Due to the unique make-up of the individual dose the bioavailability is a mere 17%.

Remodulin– This is a treprostinil based drug that is dosed by injection. Due to the delivery method the bioavailability is 100%.

Tyvaso– This is a treprostinil based drug that is dosed by inhalation where the drug is dispersed as a mist to the patient’s lungs.( Section 12.3-Pharmacokinetics) In a three-period crossover study, the bioavailability of two single doses of Tyvaso (18 mcg and 36 mcg) was compared with that of intravenous treprostinil in 18 healthy volunteers. Mean estimates of the absolute systemic bioavailability of treprostinil after inhalation were approximately 64% (18 mcg) and 72% (36 mcg). It should be noted, these bioavailability results are reflective of healthy trial subjects (non-PAH sufferers).

Remodulin Implantable System for Remodulin (ISR)-This a treprostinil based drug delivery via an implanted pump. Based on the fact this delivery system is directed dose into a patient’s vein, the bioavailability is 100%. The Food and Drug Administration (FDA) has approved the Implantable System for Remodulin (ISR). The drug was based on a collaboration between United Therapeutics Corporation and Medtronic. The ISR is approved for adults with functional class I, II and III pulmonary arterial hypertension (PAH) who are receiving intravenous (IV) treprostinil therapy. United Therapeutics and Medtronic expect to begin broad distribution of a new generation of implantable device in late 2019. On average, they estimated that patients spent approximately 2.5 hours per week managing their IV treprostinil before the study. With the Implantable System for Remodulin, they estimated that this time decreased to about 35 minutes per week. Patients on the Implantable System for Remodulin will need to have the pump refilled by a health care professional approximately every 12-16 weeks, depending on the dose of the medication. There has been nearly a decade of work in bringing this new delivery method for three classes of patients suffering this debilitating disease –Class I, Class II, and Class III patients already using Remodulin by injections.

Remunity- This is a treprostinil based drug that is delivered through a subcutaneous pump. The FDA has cleared this system, a delivery system developed by United Therapeutics and DEKA, a small private New Hampshire based medical development company.

The RemUnity system is approved for subcutaneous delivery of Remodulin via a small pump intended to have a service life of at least 3 years and be used on WHO Group 1 patients. The system will work in tandem with prefilled cartridges of Remodulin; DEKA will submit a 510(k) filing to the FDA to gain clearance for the cartridges (the RemUnity system launch is dependent on this clearance). The Companies are also developing a version of the system that includes disposable prefilled cartridges. Due to the delivery mode, bioavailability should be 100%.

At this time, due to the fact DEKA must get the 510(k) approval from the FDA, the timing when the product will be on the market is merely speculation. However, the facts being, United has FDA clearance for this product. When the refill cartridges get the required FDA approval there will be another treprostinil based product that will have better bioavailability than any inhaled version of the same product having a cumbersome and time-consuming dosing regimen.

Trevyent – This is another treprostinil based drug where the drug is delivered by a patch pump, the world’s first pre-filled, pre-programmed infusion system containing treprostinil. The drug was developed by SteadyMed, who United Therapeutics agreed to purchase in April 2018. The agreed purchase price was $141 million upfront, plus an additional $75 million based on future commercialization results. SteadyMed’s proprietary PatchPump,, a sterile pre-filled, pre-programmed, single use disposable infusion system that contains a two day supply of treprostinil. Now under total ownership by United, they received on September 11, 2019, a notice from the FDA their NDA resubmission had been accepted with a decision date projected for April 27, 2020.

Treprostinil Technosphere- This is the treprostinil based drug candidate developed by MannKind using the dry powder inhalation system they have named Technosphere. United created a partnership deal for the drug back on September 4 th, 2018. Under the terms of the agreement, MannKind Corporation received an upfront payment of$45 million and potential milestone payments of up to$50 million, dependent upon the achievement of specific development targets. MannKind will also be entitled to receive low double-digit royalties on net sales of the product.

My issue with this extensive list of United Therapeuctics products is simply why is MannKind’s product the outlier for getting attention from United.

Back on February 27 th, 2019, during their 4 th-Q, 2018 report discussion they indicated they planned to start the required Phase III trial during the second quarter of 2019. Today, September 14 th, 2019, they (MNKD or UTHR) have issued no public confirmation notice that the trial has been started.

This array of PAH products, where tresprostinil is the active ingredient, totals 7 individual products under the marketing control of United Therapeutics. In this extremely large group of products they are all FDA approved or currently under NDA reviews with the FDA — with the exception being MannKind’s product. This list doesn’t include the newest potential PAH drug that United now has the marketing rights –ralinepag. This drug candidate was created by Arena (ARNA)where they have partnered it with United where Arena got an upfront payment of $800 million, low double-digit royalties upon FDA approval and launch. And the final part of this lucrative deal is the fact Arena is subject to receive $400 million in milestone payments.

IMO—investors should be requesting answers from the responsible parties as they relate to this critical issue of the dormant development with Treprostinil Technosphere.

The Outliers in the Tresprostinil Market in PAH!

In direct competition with MannKind’s candidate we find Liquidia (LQDA) and their dry powder inhalation product that uses an FDA approved inhalation device that allows up to two breaths for each dose of their tresprostinil drug. It also should be noted that Liquidia has clinically tested their product with PAH patients in Class I, Class II, and Class III. MannKind’s indication reflects they are looking only at treating patients in the Class I category. The Liquidia candidate is already in Phase III clinical testing, where their production process will allow them to produce their drug for much less than MannKind will be able to accomplish. At this stage of development, MannKind has never dosed one patient having been diagnosed with PAH – they have only tested a small number of healthy subjects. Liquidia expects their Phase III clinical trial will be completed by the end of 2019.

So, in final consideration, it’s MannKind’s candidate that is the outlier even though they have a partnership with United. MannKind announced in June 2018 their tresprostinil candidate was ready for Phase III testing. In February 2019, United stated they would start their Phase III clinical trial before the end of the second quarter – 2019. That hasn’t happened, or at least it hasn’t been formally announced to the public.

The Real Issue That I Have with MannKind:

At the 2019 H.C. Wainwrights’ Investment Conference (9/9/2019) MannKind’s CEO made the following statement:

Now last one is Epinephrine. The reason we’re excited about Epi is, we fill out the high potency manufacturing area. We’ve finished that in July. And now that’s done, we have the capability and ability to manufacture Epinephrine. It’s really about will the FDA allow us to have injunctive indications. For example, I have an allergic reaction, I inhale Epi and if I don’t get a response in five minutes, I inject my EpiPen. It’s very can we get that injunctive indication, because in that population a lot of people wait, they take Benadryl and then they get in trouble. And our goal is to really prevent that first step from happening.”

I’m assuming my readers might not be familiar with what an injunctive indication for a medical situation involves. How ironic, the FDA gave us the perfect example on Friday, 9/13/2019, when their NDA panel for approving a drug created by Aimmune (AIMT).

Among the potential REMS steps, the panel discussed ensuring patients prescribed the Aimmune drug, the prescriber must also issue a valid prescription for injectable epinephrine.—that being the well proven and safety laden Epi-Pen, The caregiver or patient then must carry at all times, both drugs. In the case for MannKind that would be their inhaled product and the Epi-Pen where MannKind appears to have fully admitted they would require the Epi-Pen as his back-up life saver should the MannKind product fail.

Even though MannKind is now promoting that Technosphere delivers a 70% bioavailability for their drug candidates, why would they admit for their proposed epinephrine drug, it will depend on the FDA making it mandatory their #1 competitor product be their safeguard when a patient’s life is at risk because of the failure of their product? Considering the current public outcry about the cost for Epi-Pens, who thinks that forcing a parent or caregiver into buying two products, with the same ingredient being used in both and they will be happy to spend that extra money? Who thinks that an insurance company is going to pay for two drugs, especially when MannKind is admitting their product isn’t as effective as an Epi-Pen?

How did MannKind arrive at the fact they would need an assist from an FDA injunctive requirement before they had tested the product in a human— IF they knew their technology consistently delivered 70% of their drug load to a patient’s deep lungs. Only MannKind has that answer for the investors! I would consider this critical information if I owned shares of their stock! But one can’t later complain they haven’t been told the answer to the issue at the Wainwright conference on September 9th, 2019!

The stock market doesn’t reward every investor just because they bought stock in a company!

Conclusion:

Based on recent developments related to public statements shared, has MannKind admitted there are flaws with their Technosphere technology platform? Why is their only product on the market now showing no growth in three critical data points –new prescriptions, refills, and the resulting revenue stream? Why have are they now speculating on expanding their pipeline, where for more than a year they proclaimed their tresprosntinil pipeline candidate was ready for Phase III testing, yet it has been dormant for about 15 months. Now they openly speculate about their future pipeline will include an epinephrine candidate where they admit the FDA must co-approve an injunctive product that is the dominate player in the epinephrine market—Epi-Pens. If they consider it a wise decision to develop an epinephrine product, how did they know it would depend on the FDA requiring the patient also buying the competitor’s products. The reason this is such a critical issue, MannKind has never tested their ‘potential’ epinephrine product in a human, so how do they know their Technosphere technology can’t deliver the dosages as compared to the SOC product—the Epi-Pen? Since the same active ingredients is found in both products—why would MannKind’s product need a readily available and identical product as a back-up for the users?

Therefore, I think it would be a good idea for Mr. Osborne to conduct another ‘fireside chat’. Don’t investors deserve having the answers for my conundrum of issues I’ve outlined?

It is my hope and desire that Afrezza remains available for patients needing options in treating their medical condition. However, the mere fact there are some who have their hard-earned money tied up in MannKInd’s stock and Second Sight’s stock—the stock market has no obligation to make every investor RICH!

Good luck with your future investing decisions!

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Editor’s Note: This article covers one or more microcap stocks. Please be aware of the risks associated with these stocks.

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2019-10-06