SFY - MannKind: The Continuing Saga Of What They Say Vs. What They Do

Summary

• Readers will be updated on previous articles where I discuss the issues MannKind faces with their business model.
• I will discuss their planned development of clofazimine and the issues they face.
• I will discuss the need for MannKind to adopt a new business model.

" Keep in mind that the past is not history but a much vaster region of the dead, gone, unknowable, or forgotten. History is what we choose to remember." -- James J. Ellis, Pulitzer Prize-Winning Historian

On October 2, 2014, I wrote and shared my first article here on Seeking Alpha that offered my opinion about MannKind ( MNKD ). We are now into the tenth calendar year since these first comments on my part about the future of MannKind and their first commercial product—Afrezza. As we approach another pivotal point for MannKind I thought it might be good to review the history of MannKind, the key players, and critical events that were part of their history.

Since their eventful Adcom meeting on April 15, 2014, when the FDA formed committee voted for the FDA to approve Afrezza, the stock traded as high as $11.48. There were several events during this period until October 1st, 2014, the day before my article was published. These events include:

• FDA approval of Afrezza
• Partnership Deal with Sanofi (SNY)
• Receipt of $150 million upfront payment

However, on October 1st, 2014, the stock had retreated from the $11.48 interim high by slightly more than 50%.

In the following commentary, I would like to share a host of reasons that might explain what has been construed as good news for MannKind investors, where the underlying reality of the situation is showing there isn't much good news for MannKind investors as it relates to Afrezza.

This is the closing paragraph of my first article about MannKind:

So, what gave those shorting, or merely wanting to sell their shares, a reason to either sell or add to their short position? I hope that some of the points I've pointed out might shed some light on this causation! Overlooking the details of an investment opportunity is often a cumbersome undertaking for the lay investor; however, if one ignores the details, they need to understand that the savvy Wall Street gurus search the SEC disclosure with a discerning eye for critical issues. It should be evident to Doubting Thomas's investors that the steep decline in MannKind's stock goes back to the SEC filings on April 11th, 2014. With all the supposedly critical milestones needed to skyrocket the price of MannKind's stock, most have occurred. With my paraphrasing the first transmission made by the Apollo 13 astronauts-MannKind investors, you have a problem!

Always remember, DENIAL isn't a river in Africa!

In February 2023, based on a 1-5 reverse split in MannKind’s stock, those owning their stock in 2014, they have seen their shares increase by $0.16 a share based on the current $5.16 valuation of their shares.

To understand the complete history of MannKind and Afrezza, one must go back to 1991, thirty-two years ago.

• In 1991 Solomon Steiner applied to incorporate Pharmaceutical Discovery Corporation.
• PDC was created to develop drug delivery technologies, specializing in pulmonary delivery systems.
• In 1994 PDC filed the first patent for Technosphere Technology.
• In 1997, Al Mann saw the potential of a dry powder insulin formulation to change how diabetes is treated.
• In 2000 an IND for Technosphere insulin was submitted to the FDA. And PDC relocates to Danbury, CT.
• In 2001 MannKind purchased Pharmaceutical Discovery from Solomon Steiner; with this purchase, MannKind acquired the Technosphere molecule and Medtone inhaler, both used in developing its lead product, Afrezza (inhalable insulin.)
• In 2008 the commercial manufacturing facility in Danbury was expanded and renovated.
• In 2009 MannKind submitted to the FDA an NDA for Technosphere insulin. The FDA denied the approval of this NDA filing.
• In 2011, additional Phase 3 studies of Technosphere were conducted using a next-generation inhaler (Dreamboat)
• FDA approved Afrezza on June 27, 2014.This was based on the third NDA that MannKind had to undertake with the FDA.
• 2015 formulation work started on Treprostinil Technosphere (TREt). From this initiation of pre-clinical work, it took until 2022, seven years, for them to get FDA approval for their effort in applying their Technosphere system to an already FDA-approved drug-Tyvaso.
• On January 5, 2016, MannKind Corporation and Sanofi terminated their license and collaboration agreement.

With Sanofi opting out of the deal with MannKind, they now had complete control of the product, and apparently, there were no other drug companies interested in taking Sanofi’s place. It was now MannKind’s job to market Afrezza.

On September 4, 2018, United Therapeutics announced they had collaborated with MannKind to use Technosphere Technology to create a new formulation and delivery of their Tyvaso PAH drug. Therefore, since the first patent for Technosphere Technology occurred in 1994, this means that over the ensuing twenty-four years, MannKind and United Therapeutics are the only two drug companies that have opted to use MannKind’s Technosphere system to develop a drug product. Even MannKind, in their effort to create their second drug candidate for actual FDA-approved clinical trials, clofazimine, opted to use a mere 165-year-old system for their delivery method. Such a delivery method was created in 1858 by a Frenchman named Sales-Giron—a nebulizer used for the same product that United Therapeutics uses for Tyvaso.

Based on two drugs using the Technosphere system MannKind executives continue to insist their inhaler is the best system for delivering a drug to a human lung. Yet when you look at this 2019 report on the Top 20-global-respiratory-inhaler-manufacturers MannKind does not make this list. There is a straightforward reason this is the case—there are no drug companies, other than United, that have opted to use Technosphere. But in the case of United, they had an ulterior motive to seek the cheapest deal for getting a DPI quickly on the market. I wrote about this issue in my June 29, 2022, article titled - Liquidia vs MannKind: Tresprotinil Is the Big ‘If’. Since writing this article and making a case for Liquidia ( LQDA ) ultimately winning this battle, their stock is up 56%. And currently, Liquidia garners more than a 30% valuation for their stock vs. MannKind’s stock.

On February 2, 2023, the Patent Trial and Appeal Board reaffirmed their decision to invalidate all charges of United’s patent related to Liquidia’s case against them. The CEO of Liquidia indicated that a final legal resolution should occur in late 2023 or the first half of 2024.

Afrezza’s Woes

Now MannKind oversees the marketing of Afrezza. We are now into 2023, and this is the 8th year that Afrezza has been on the market. And what I wrote about in 2014, as it relates to Afrezza, what I predicted has happened.

Before MannKind got FDA approval, about 6,500 clinical trial patients had participated in the MannKind effort to obtain FDA approval for Afrezza. At the same time MannKind was developing Afrezza, Pfizer had ceased to market the first inhaled insulin product Exubera. Pfizer determined early on that diabetic patients, and insurance companies were not on board for using their inhaled insulin.

Two of the most prominent players in the human insulin market, Eli Lilly ( LLY ) and Novartis ( NVS ), each had inhaled insulin products in Phase III developed. One must remember, MannKind had two NDAs rejected by the FDA. It was only in their third NDA effort that they finally got the FDA approval for Afrezza.

Anybody who wanted to know what MannKind’s trial data revealed had full access to what MannKind filed with the FDA. Lilly, Novartis, and even the media saw the data that MannKind had obtained. When the FDA holds an ADCOM meeting for an NDA filed by a drug company, the clinical data is open for scrutiny by anyone that wants to see the data. Lilly and Novartis knew what their Phase III data was showing, and now they could see what MannKind’s data was showing---Lilly and Novartis shut down their development program for such as product—inhaled insulin. Thus, saving them hundreds of millions of dollars. When Al Mann opted to rename the original company to MannKind, even Solomon Steiner told Mann this was a bad idea. Now his name was attached to their inhaled insulin, and Al Mann would have to spend the money to save his namesake.

I have attended an ADCOM related to a drug filed by AstraZeneca ( AZN ). I attended this meeting merely to see how the FDA made decisions about drugs they were reviewing. During the hearing, many issues were raised by the FDA for the panel of medical experts to resolve. The presentation by AstraZeneca was awe-inspiring. I have attended many presentations, sometimes making presentations and others just listening. The head of the AstraZeneca marketing team, considering the nature of the subject, was most impressive in his presentation.

At the end of the day, the negative issues that the FDA raised some of the professional panel ignored them. The panel’s vote was not unanimous, but the majority for approval prevailed, and the FDA subsequently approved the drug. AstraZeneca launched the drug, and as with Pfizer and now with MannKind we find that the issue raised by the FDA, based on a company’s NDA data, the drug can fail in the market. This one did!

Even newspaper reporters have access to such clinical data and write articles for their readers to see the issues. This New York Times article , seven years before the FDA approved Afrezza, reveals key issues plaguing Afrezza. And it doesn’t look good when a company’s Chief Medical Officer sues the company for hiding information from the FDA about a drug they are developing. But this was the case with MannKind and their CMO. Then in 2010, John Arditi, Vice President of Worldwide Regulatory Affairs, sued MannKind for the same reason as Dr. Wayman. Both cases appear to have been settled by MannKind with undisclosed payments to the plaintiffs. Citing this historical record of two MannKind executives seeking legal redress from MannKind, there is no implied pejorative claim by this writer that this issue relates to current MannKind key executives.

Key points made in this NYT article:

• Not being superior to injectable insulin in lowering average glucose levels.
• Not being able to maintain the trial patients using Afrezza compared to those using injectable insulin.

In any case, MannKind has yet to show that its insulin is better than others, and some suggest it might even be too short-acting. In clinical trials, it has lowered average glucose less than a fast-acting injected insulin, though the differences were not statistically significant. The point is that it has never been able to show it was superior to the cheaper injected insulins.

Al Mann’s Talks About the Issues

This is a link to an Al Mann in-depth interview with a significant publication for diabetes information. The interview took place in September 2014, before the launch of Afrezza in January 2015. As you read what was said in the interview, note the hedging and dodging done by Al Mann for the interviewer’s questions. Note some of these topics:

• MannKind laughs at Pfizer and Exubera for their pending failure.
• When asked about the trial patient dropout rate, Mann did not know the rate but contended it was the comparator group that was higher.

Strangely, he knew the comparator was higher but didn’t know Afrezza’s rate of dropouts. But for seven years, it was common knowledge that the dropout rate for Afrezza trial patients was a significant issue. Read the NYTs article from 2007 that is linked above in this article. And it should be noted that MannKind is obligated to the FDA to conduct a Phase IV trial with 800 patients, looking at safety issues. The problem with the delay of this critical trial---they can’t find enough patients necessary for this to happen---because of the dropout rate.

Heed what Al Mann stated about the goal is lowering the patient’s HbA1c levels. But we know that in all the trials done by MannKind, they can’t show data indicating Afrezza is superior to injected insulin as it relates to HbA1c levels. It is also essential to see Al Mann stating that dosing Afrezza might require more than one dose by the patients. Al Mann stated that it might require a patient to take 4X what the patient would require with injected insulin.

For every prescription filled for Afrezza, the package insert states very clearly the issue with getting Afrezza out of the cartridge and into the lungs of the patient. This is the link for the source for the bioavailability of MannKind's dry powder-based Technosphere delivery system Section 12: Carrier Particles.

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.

When a patient doses a medication, and only 39% of the dose enters the patient’s body, that indicates a significant issue with the delivery system. In this case the Technosphere system that is touted as the best on the market.

The Numbers Speak for Themselves

At the end of the day, the most crucial thing that MannKind should be concerned with is the number of new prescriptions and refills that the patients are purchasing. The universal way this is done is by using the weekly reporting from the Symphony data.

Looking at the complete data for 2022, we see the following data points:

* NRx’s— 16,010

* Weekly NRxs –308

* Refills Weekly Average -442

Looking back to 2015, when Sanofi first launched Afrezza into the market for the weekly report for 10/30/2015, Sanofi had 421 NRxs filled by new patients. For the weekly report for 9/4/2015, Sanofi obtained 232 refills from patients.

Starting with the data generated in 2015, where Sanofi was achieving 421 weekly new prescriptions, and now with 2022 data showing that for the year MannKind averaged 308 prescriptions per week, it begs to ask when will MannKind ever generate enough revenue to cover the cost of producing and marketing Afrezza. As if the NRx data isn't dismal, when you look at the refills for Afrezza you find they were averaging only 442 refills a week in 2022. In the ninth calendar year for marketing Afrezza this makes their situation direr forever for making a profit based on the expenses associated with the product. At this stage of marketing Afrezza the refills should be running in the tens of thousands range for weekly data. Denying this fact will never change the historical results that Technosphere has achieved with Afrezza.

Pfizer, Sanofi, Eli Lilly, and Novartis made business decisions based on data showing that inhaled insulin would not be a profitable drug for them to spend their cash on. Al Mann stated that they laughed at Pfizer for their attempt to market their inhaled insulin, and now we know that on MannKind’s financial books, they are carrying more than $3.0 billion as a loss related to the funding of Afrezza.

The Folly with Clofazimine as The Next Drug on MannKind’s List of Successes?

In December 2020, Dr. Thomas Hofmann sold to MannKind his company, Qrupharma, which he operated out of a barn behind his home in Pennsylvania. The selling price was $3.5 million in cash and $9.5 million in MannKind stock shares. We know from governmental records that Dr. Hofmann sought federal tax dollars for more than $500,000.00. Since his filing for this money occurred in 2017, we know he was experimenting and working with clofazimine no later than 2017, probably much earlier. I state this because, in his filing for these federal dollars, he indicated it was to be used for a Phase I study with a clofazimine inhalation formulation. Since he was ready to start a Phase I trial, one can assume he had completed pre-clinical trials before filing for Phase I, which would be for humans using the drug candidate—clofazimine. But let’s use 2017 to start his work preparing for this Phase I clinical trial that would require FDA approval –2017, 2018, 2019, 2020, 2021, 2022. It was in the first Q-2022 before MannKind started their Phase I FDA-approved clinical trial. If, in 2017, Dr. Hofmann was seeking money($500,000.00) to conduct a Phase I trial, why did MannKind spend $12.0 million of their capital assets when they could have done the preclinical work themselves for well less than $12.0 million?

But putting aside this questionable spending capital issue, what did the Phase I clinical show when MannKind announced on 9/6/22 that the trial was completed?

The crucial part of the press release was this part:

“Study MKC-CI -001 was a Phase I randomized, double-blind, placebo-controlled, single- ('SAD') and multiple-ascending dose ('MAD'8) study to evaluate the safety, tolerability, and pharmacokinetics ('PK') of MNKD-101 in healthy volunteers. The key safety findings of the study included:

• Clofazimine inhalation solution found to be generally well tolerated at daily doses of up to 90 mg over seven days
• No lab abnormalities, QT prolongation, or serious adverse events identified.”

First, the press release does not exactly share the key safety findings of the study. This was one pill a day for the seven-day dosing regimen with individuals having no medical lung issues. If approved by the FDA, those suffering from this disease will take many months for them using the drug to remediate and hopefully cure them of this disease. This is what MannKind stated in their press release:

Additional data collected during the MKC-CI-001 study is currently undergoing final analysis. Detailed data findings will be presented in upcoming publications and scientific conferences.”

This is called ‘kicking the can down the road,’ which is the parlance of delaying something being known, in this case, the FDA. Note for this tiny group of healthy trial patients that MannKind stated that “generally” clofazimine dosing was well tolerated. Using “ generally” as the adjective is not the same as “well” tolerated.

This is what MannKind stated in their 9/6/22 press release:

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation ((MNKD))., a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that it has successfully completed a Phase 1 study of clofazimine inhalation suspension ( MNKD 101 ) and is planning discussions with the U.S. Food and Drug Administration (FDA) regarding results and the ongoing clinical program .

And now we know that, in December of 2022, MannKind discussed their Phase I study with the FDA about the “ongoing clinical program”. When a drug company finishes a Phase I study, they seek a meeting with the FDA to get the critical approval needed for the next positive step forward in clinical trials. That being the approval to move into a Phase II study where in the case of clofazimine, we are talking about patients suffering from this horrid disease. A seven-day regimen is out of the question for treating the indicated disease. Anyone approaching the FDA with such a limited number of doses being suggested this meeting would summarily be ended as a waste of time. And that is apparently what happened with MannKind’s meeting because:

On January 23, 2023, MannKind said clofazimine inhalation suspension (MNKD 101) would advance to an adaptive phase 2/3 study.

In addition, the company noted that a paper was published in the American Society for Microbiology journal Antimicrobial Agents and Chemotherapy examining the potential of treating nontuberculous mycobacterial ('NTM') infection through direct delivery of inhaled clofazimine to the lungs, overcoming the systemic toxicity witnessed in oral treatments. The readers should understand that this paper is based on dosing dogs with clofazimine for a few days.

MannKind said direct delivery of clofazimine to the lungs may provide a treatment option for NTM lung disease, which potentially overcomes systemic toxicity and lessens side effects .

We are encouraged by the preclinical and Phase 1 data, and how inhaled clofazimine may finally resolve these issues and most importantly, provide patients with a potentially improved NTM therapy," said MannKind CEO Michael Castagna.

For example, the fact that no animal was reported to have any skin discoloration is promising in reducing a primary adverse effect of CFZ administration in humans, skin discoloration.”

Medical science and related clinical trials are filled with data concerning the reality that those being dosed with clofazimine nearly 100% of them experience discoloration of their skin. Plus, according to the clinical data from previously conducted clofazimine trials, the drug accumulates as crystalized in various organs of the human body. And now MannKind’s efforts are based on the drug being dosed to the human patient’s lungs, with such dosing being over an extended period. I find it disingenuous for MannKind to state that the dog’s skin showed no discoloration, but they failed to mention if the dog’s lungs had discoloration.

MannKind stated they would make a full report on the data found in the Phase I trial. Instead, they share data collected from dogs where they talk about the lack of skin discoloration, but even in this disclosure report, they never mention a human lung being dosed with clofazimine. Is it "generally" or "well" tolerated for lung discoloration associated with clofazimine? The FDA might be telling us by denying them the Phase II trial.

Adaptive Designed Clinical Trials

There are issues with the approach MannKind takes with their adaptive Phase 2/3 trial for clofazimine. The FDA approved such trials about 25 years ago. The issue with using this approach is the allowance of arbitrary changes by the drug company in trial protocols opens up the more significant potential for skewing trial data. Being allowed to simply drop a patient who was accepted based on trial protocol and then being able to drop this patient could open up a can of worms for the drug company. This is a scholarly article that outlines why the FDA puts such trials under a giant microscope and why MannKind and others must submit their protocols to allow them to take this approach in seeking FDA approval. This also explains why most drug companies submit well-defined protocols and skip even seeking an adaptive designed clinical trial. Before one gets excited about MannKind using the adaptive designed approach, they should wait and see what they submit to the FDA for their protocols.

Time to Cut to the Chase on Who is Developing Clofazimine for This Lung Disease

In 2021 I wrote an entire article about the many promises of the Bluhale inhaler device that would revolutionize the inhaler market. The article was Bluhale or Just Smoke? Now three calendars years later--still no Bluhale inhaler for those using Afrezza.

Going back in the history of MannKind, it is hard to forget the number of years they promoted they were working on developing an alternate product that would compete with the Epi-Pen for dosing someone experiencing a severe allergic reaction. The drug used is epinephrine, directly injected into the patient. This is a deadly situation needing medical attention. Pfizer owns Epi-Pen, and MannKind said they would create and get approved for an inhaled version of epinephrine. MannKind met with the FDA, where they outlined their development plans---obviously, the meeting didn’t go well for MannKind. They summarily announced they were canceling plans to create such a drug delivery product---inhaled using the Technosphere system. MannKind never publicly stated the FDA’s issue against such a product.

We have the same scenario with MannKind approaching the FDA with a proposal for another drug. Now we know they were not successful in getting the approval for moving ahead in the normal process of getting such drugs approved for human use.

The question for MannKind and my readers is, has anyone gotten approval for using clofazimine to treat the lung disease that MannKind is proposing? The answer would be no— but Novartis, the company that holds the patent for lamprene (clofazimine) is trying, and they currently have their clinical trial in Phase III. Novartis has Investigative Sites in 44 states and two provinces in Canada. In total, they have more than 100 such sites. In Florida, they have more than 20 sites seeking patients for their clinical trial. For the complete list of where these sites are located, they can be seen on Novartis' official FDA site for this clinical trial. This is the FDA site for Clinical Trials being conducted with clofazimine, the drug owned by Novartis.

Brief Summary :

Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria ('NTM').

To be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.”

As pointed out in this clinical trial data, Novartis is the only company with a patent on clofazimine with the drug - lamprene . They no longer make the drug available through pharmacies. Still, they make it accessible through their expanded access program for use with leprosy patients and based on their physician requesting it from Novartis. Now with Novartis seeking through this clinical trial, they will find out if Lamprene might be effective with this lung disease. If this trial proves that it does work, then Novartis will make their drug available through their expanded access program under the same terms as the leprosy doctors.

This type of program is known as a compassionate use allocation. If this clinical trial being conducted by Novartis through the auspice of the FDA if it proves successful and the FDA approves, what about the issue of Novartis now obtaining a new patent for clofazimine for treating non-tuberculous mycobacteria ('NTM')? The Novartis trial began in 2020 and is still ongoing in 2023. Can MannKind find enough patients for their trials, and can MannKind afford at least four years to gather enough data for their clinical trial, as indeed the FDA will require the same amount of data as Novartis is gathering? And Novartis has decades of data already in their hands for oral delivery of clofazimine, and now MannKind proposes it will be inhaled directly into the patient's lungs.

Novartis is a world leader in developing inhaled products using inhalers. Their Tobi((R)) Podhaler is one example of their advanced delivery systems. With Novartis' ownership of clofazimine and their expertise in inhaled drugs, I think it would be ludicrous to assume they never considered using an inhaler to deliver clofazimine to a trial patient.

The point of this discussion is to convey that Novartis is miles ahead of MannKind's effort to get clofazimine approved by the FDA for use as a compassionate drug for treating non-tuberculous mycobacteria ('NTM'). The logic would be that the FDA will require a massive and long-term review of what is known as a drug with many debilitating side effects --skin discoloration and crystalized deposits in the body being just two of them. The skin/flesh issue occurs in nearly 100% of patients, and MannKind's proposal to deliver it to a patient's lungs--much can go wrong!

Conclusion

The growth in developing inhaled drugs has left MannKind behind, and other drug companies are expanding their products annually. Approaching ten calendar years after Afrezza was on the market, and current adoption and retention rates not showing any sign of improvement, historical financial data indicates Afrezza revenue has never generated a profit for MannKind. For the most visual example of MannKind's central problem, one can compare Afrezza with Novolog or Lantus on Goodrx.com --Novolog is $59.85 vs. Afrezza is $1,747.00.

At some point, MannKind must look at the financial drain that Afrezza presents for them. What is a better example contained in this article? Novartis is a multi-billion dollar company because its executives make hard decisions like stopping their effort to market clofazimine and removing it from the market. As a good corporation, they now make the drug available by request to a doctor who would like to treat a patient with the drug. MannKind could take the same approach for Afrezza.

With MannKind now subject to start dosing patients suffering from ('NTM') with inhaled clofazimine, the first sign that huge numbers start seeing their skin discoloration issue and then find that their lungs are beginning to show the same issue, historical records show a vast major opt to stop using the drug.

Can MannKind afford to take on Novartis in this battle, considering Novartis controls the supply of clofazimine?

Then MannKind is facing the growing potential that Liquidia will be entering the market by the end of 2023 or earlier in 2024. And based on the manufacturing cost between the competing drugs, MannKind will be hard-pressed to win this battle because of their inherent expensive manufacturing process.

MannKind has built there business model around its Technosphere Technology system. Now with a history of twenty-four years, they have two products on the market because the vast majority have moved on to delivering their own inhaled products without employing the service of MannKind. It is my opinion that MannKind needs to develop a new business model sans the use of Technosphere Technology.

I hope that MannKind can keep supplying Afrezza to those who need options for treating their medical conduction. This could be done with a compassionate use program.

Good luck with your future investing decisions!

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