Another Delay for MannKind
This morning MannKind (NASDAQ:MNKD) announced the FDA has delayed making a final decision on Afrezza® for another 4 weeks. According to a press release issued by the company; “MannKind Corporation (Nasdaq: MNKD) today announced that it was informed on December 27, 2010 by the U.S. Food & Drug Administration (FDA) that the agency will not be able to complete the review of the New Drug Application (NDA) for AFREZZA(R) (insulin human [rDNA origin]) Inhalation Powder by the action date of December 29, 2010. The FDA stated that it will require approximately four additional weeks to complete its review of the NDA.”
Shares of MannKind are up slightly on the news in very heavy trading. The question is why? Typically delays in the approval process are not seen as positive news by investors, especially for a drug like Afrezza® which Diabetic Investor believes stands a 50/50 chance of approval. In this case, it appears investors are buying into the theory that the FDA needs the additional time to dot all I’s and cross all the t’s.
Diabetic Investor isn’t buying this theory and does not believe the delay should be seen as a positive development. Although no one knows what the FDA will do or why, Diabetic Investor suspects the agency is somewhat divided on how to proceed with Afrezza®. Given that the company has provided the agency with additional data we believe there may be some new information that prompted the delay. Please note this just speculation but it is the only explanation that makes sense given the agency has had more than ample time to review Afrezza®.
Even if the FDA does approve Afrezza® Diabetic Investor remains skeptical that it will ever amount to more than a niche product and does not pose a serious threat to any of the current injectable insulin’s already on the market. As we have outlined numerous times Afrezza® faces significant hurdles in the marketplace.
Still once again MannKind shares are proving to be one of the better trading opportunities. As we have noted before this is not a stock for investors with a weak stomach. Owning shares of MannKind is like riding a roller coaster, only shares of MannKind has more twists and turns. With a decision just a few short weeks away, the ride is about to come to an end.