Recent Posts

Aug 16, 2018 8:16:50 GMT -5 dh4mizzou said:

mnholdem,

You ever post/publish on SA ;-)

And you really need to forward this to Mike C. and Dr. Kendall.

I was also thinking of publishing an article, "MannKind Prepares to Release Nearly 20 Years of Clinical Data" which would highlight remarks made by CEO Castagna and CMO David Kendall at recent conferences, highlighting Dr. Kendall's lung safety presentation scheduled for the upcoming EASD.

In my opinion, MannKind should be regularly issuing press releases like this for dissemination to media outlets. No company is permitted to pay for favorable press coverage, but MannKind can certainly tailor messages about Afrezza and TreT through press releases. Media outlets in both the medical and investment communities are always looking for stories to fill their pages and press releases work just fine. Sometimes reporters even call to get more information.

It's an area that I hope MannKind's new marketing director doesn't ignore. Used effectively, press releases can be terrific tools.

For decades, studies have conclusively demonstrated that early intensive insulin therapy administered to newly-diagnosed Type 2 diabetes patients can result in remission of the disease.  One meta-analysis report, conducted more than a decade ago and involving over 3,000 patients, demonstrated results of nearly 50% of patients who underwent early intensive insulin therapy achieving drug-free remission for up to two years. Clinical data has also demonstrated that early intensive insulin therapy has resulted in a significant reduction of insulin resistance, a common precursor of Type 2 diabetes.

In a clinical study by Model Clinical Research LLC, Baltimore MD, in collaboration with MannKind Corporation, investigators are seeking to demonstrate that the addition of mealtime Afrezza (aka Technosphere Insulin) can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.

The trial protocol instructs patients to follow a weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm.

In spite of growing clinical evidence that early initiation of insulin therapy has repeatedly demonstrated significant results, including complete remission of the disease, the American Diabetes Association still has insulin therapy as the last step in its Diabetes Standards of Care.

In early stages of Type 2 diabetes, insulin resistance and other factors often causes the pancreas to become over-stressed and unable to keep up with the body's demand for insulin. In layman's terms, the beta cells in the pancreas begin to wear out. Critics of the ADA and the AACE are becoming increasingly vocal in their dissent against the recommendation within the ADA's Standard of Care which advocates early treatment of diabetes with oral medications, such as Metformin, stating that Metformin does nothing to assist the pancreas or improve its ability to produce sufficient levels of insulin. Early intensive insulin therapy, on the other hand, can provide a respite to the over-stressed pancreas by providing much-needed insulin and enabling the pancreas to recuperated and generate new insulin-producing beta cells at a rate that will meet the body's demand while, at the same time, lowering insulin resistance.

Recently, the American Diabetes Association announced changes that would enable the organization to more rapidly response to scientific discoveries for the treatment of diabetes, stating in a press release that, "Beginning with the 2018 ADA Standards of Medical Care in Diabetes, the Standards document will be a “living” document where notable updates are incorporated into the Standards, as determined appropriate by the Professional Practice Committee, noting that their decades-long practice of annually reviewing medical advances would be replaced with more frequent updates, what they described as a "living" Standards of Care, in response to important events such as "new treatments with the potential to impact patient care" and publication of new findings "that support a change to a recommendation and/or evidence level of a recommendation".

Many critics of the ADA are advocating that there is now more than sufficient clinical evidence to meet the ADA's criteria to update its Standard of Care to move short-term intensive insulin therapy to the first step in treating early diabetes. It's hard to argue with results and the incredible potential of this therapy, its puzzling why the ADA has taken so long to advocate early short-term insulin therapy as a first step in combatting this disease. I know of no other treatment that has the potential of remission of diabetes for 50% of treated patients.

Delaying this therapy may result in continuous deterioration of the pancreas to the point where it is no longer repairable and sentences the patient to a difficult life of continuously fighting diabetes. It's a fight that can be won with a 1st Round knockout. It's time for the American Diabetes Association and the American Association of Clinical Endocrinologists to recognize this important treatment and to put it in its proper place in the 2019 ADA Standards of Medical Care in Diabetes.

The clinical trial, entitled "Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients" is scheduled to be completed in September 2018.

Trial Link: clinicaltrials.gov/ct2/show/NCT03324776?term=mannkind&recrs=abdfg&rank=3

Aug 10, 2018 8:26:10 GMT -5 standup said:

You've removed a few few of my postings that I felt were relevant to MNKD.  Obviously, you didn't agree and you remove them without comment.  It makes me wonder how many other postings have been removed that I or others might have found interesting or relevant.

I think your goal should be balance and not biased in one direction.

I'm starting to think you're now the opposing position of Seeking Alpha were my positive MNKD postings never see the light of day.

Give it some thought.

Perhaps you are referring to your posting of this morning's announcement that Ontario-based Aralez Pharmaceuticals entered an agreement to sell its assets to two separate companies, Nuvo Pharmaceuticals and Deerfield Management Companies, as it files for bankruptcy.

The event has absolutely nothing whatsoever to do with MannKind Corporation. Even the title of your thread "No Parallels, Please" attest to this face. Perhaps you can locate a stock discussion board for Aralez or Nuvo and post it there?

Thank you!

Satisfying the Deerfield debt would return MannKind's assets to the company, putting it on much more favorable footing for non-dilutive financing to fund future drug development.  Alfred Mann secured $100 million in financing from Deerfield many years ago when MannKind was still a startup biotechnology drug development company and all of the company's intellectual property, patents, technosphere drug candidates, and even the manufacturing facility in Danbury were put up as collateral.

I would think, now that company's Technosphere pulmonary drug delivery technology is proving itself and becoming more valuable, that MannKind will no longer give up 100% of its assets as security for non-dilutive funding (assuming the Deerfield debt is first satisfied) and will selectively choose which assets will be used as security.

For example, if MannKind were to secure financing to fund development of more API, then the rights to the new drugs would serve as collateral but NOT the intellectual property underlying its technology.

With only $23 million principle remaining on the Deerfield Notes (Tranches 1, 4 and B) it's entirely possible for a venture capitalist, investment firm or pharmaceutical company to buy into MannKind, pay off the Deerfield debt and secure intellectual rights to drugs (commercial or development) which it believes have potential to become big revenue-generators. It's a company's assets which give it leverage in the financial markets. As long as Deerfield holds first right to all MannKind's asset, the CFO doesn't have the leverage needed to secure future funding at favorable terms.

It's quite possible that an announcement of an Agreement, where a 'white knight' steps forward to fund MannKind's future, could indeed cause a short squeeze, particularly if it were to provide MannKind with 2 years of runway for expanding commercialization of Afrezza and expanding development of more Techosphere API in its pipeline.