A Completely Different Complete Response Letter
It must be something in the air today as Amylin (NASDAQ:AMLN) wasn’t the only company who received a complete response letter from the FDA. This morning MannKind (NASDAQ:MNKD) announced they too have received a complete response letter from the FDA for their inhalable insulin AFREZZA™.
According to a press release issued by the company; “The Complete Response letter related to the AFREZZA application requested several items, including information and currently available clinical data that support the clinical utility of AFREZZA and information about the comparability of the commercial version of the MedTone inhaler to the earlier version of this device that was used in pivotal clinical trials. The letter cited no safety concerns, but requested updated safety data related to AFREZZA. The letter also requested changes to the proposed labeling of the cartridges, foil pouches and cartons.”
Unlike Amylin shares which took off after their news, shares of MannKind are moving in the opposite direction and are currently down almost 15%. Diabetic Investor is hardly surprised by this news and as everyone knows has never been a huge fan of AFREZZA. As we have noted on many occasions the time for inhaled insulin has come and gone. Furthermore, even if AFREZZA is eventually approved it’s highly unlikely that the drug will ever reach the lofty projections touted by the company.
The company will be conducting a conference call tomorrow morning at 9 a.m. EST to discuss this news and Diabetic Investor can’t wait. While we’re sure there will be several questions on just what this means, Diabetic Investor can’t wait to see how the company put’s a positive spin on what is truly bad news. It should also be somewhat amusing to hear them answer questions on how this news will impact their much talked about but never realized partnership discussions.
The reality here is investors should have learned by now that when it comes to MannKind about all we hear is hype, all sizzle and no steak. Yet it continues to amaze Diabetic Investor that investors keep buying into this hot air balloon even when it looks like the bubble will soon burst. Even if everything goes MannKind’s way, they have huge hurdles ahead of them commercializing AFREZZA.
When it comes to MannKind it would be wise to remember the words from one of AESOP Fables, “The Dog and the Shadow”; “Beware lest you lose the substance by grasping at the shadow.”