On April 1, 2014, the much awaited ADCOM event for MannKind's Afrezza will be discussed with an FDA advisory committee. Many investors are entirely aware of the impact the resulting vote of this committee will have on MannKind's (NASDAQ:MNKD) future. This particular vote is important, because on April 15th, the FDA will render a much awaited decision on Afrezza. The FDA is not obligated to approve any drug, based soley on an advisory panel's vote, but they normally do vote in the same manner. Investors should be looking for the March 28th release of the FDA's briefing documents just a couple days earlier. These documents should give some indication as to what the FDA is thinking.
Previous history of approval for Afrezza has not been too 'Kind. However, after 2 CRL's and further sets of clinical trials, and several years later, MannKind is laying it all on the line. Recent conference calls express the company's vision that the FDA will finally give the nod and Afrezza will finally come to market. The company is burning through millions of dollars to ramp up production faciliies to meet demand in a $40+ Billion market. Analysts are now viewing the diabetic market at $32 Billion by 2018. But, the Technosphere platform, if approved, would have the company reaching for the stratosphere. In fact, in 2010, two of their facilities recieved Facility of the Year Awards. See www.news.mannkindcorp.com/phoenix.zhtml?...;highlight=
Interestingly enough, there is tons of data on the street about the Technosphere insulin platform, from the previous trials, that is availabe for patients, doctors, and potential investors alike. One that I would like to share is very interesting and chock full of great information. It can be viewed at formularyjournal.modernmedicine.com/form...-
The Technosphere platform likely has Big Pharma companies, that are deeply involved in the Diabetes market with needles, either ready to inject themselves these days, or be ready to pounce on a takeover of MannKind.
The most important thing for investors to understand now, is that, should Afrezza be approved by the FDA on April 15th, the Technosphere platform has unlimited potential in the medical community. It's reach would extend well beyond just diabetic medication use. Thus, the Technosphere platform is a complete game changer, and one the Big Pharma companies will be most interested in going forward.
It is my opinion that the value of the company lies in the Technosphere platform. And while Afrezza is the first stepping stone in MannKind's future, and a big one, FDA approval opens a whole new plethora of possibilities for "Mankind" and "MannKind." With previous failed attempts, and a couple CRL'S (Complete Response Letter) from the FDA in past years, one has to fully believe that the company is now ready for approval. Otherwise, I believe the FDA would have long ago outright rejected the platform and any future attempts to get Afrezza, or any other drug, to market using these methods. The clinical data shows its safety, efficacy, and even attributes to some weight loss under some circumstances. The clinical data also shows the even distribution of medication through the lungs. The data also shows there are no pulmonary issues.
Personally, I expect MannKind will receive FDA approval on April 15th this time around, and not only will investors cheer, but so will doctors and patients around the world. Let's face it, needles are out, and the time for newer technology is in. Big Pharma companies will have to get on board, or get left behind.
I believe the FDA has a responsibility to look to what patients are asking for when technological platforms like Technosphere are available, and as long as they are safe and effective, they should not keep them from patients. Every diabetic patient I have had the pleasure to know, always hated the needles, and always had to go hide somewhere in embarrassment to take an injection. Our world is better than that. I beleive MannKind has worked hard over the years, working with the FDA consistently, to prove their platform works and is the future. The next time a person needs to take their insulin, they should not be reaching for a needle. They should be reaching for the Technosphere.........and I believe they will.
Disclosure: I am long MNKD. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.