First a disclosure, I'm long on Mannkind and have no position in Biodel. I can't help but applaud the efforts of both Biodel and Mannkind founder.
Biodel's PDUFA is Oct 30, 2010. The stock is pricing in a potential CRL and more cash burn. There are controversies around the India trials, Injection site pain and trial sizes & lack. Another issue the detractors are happy to point out is the fact that many of Linjeta (old name was Viaject) trials were against regular human insulin.
Mannkind's PDUFA is Dec 29, 2010. Afrezza has its own share of controversies, like lung function decline, lung cancer threat, despite the fact that all those who got cancer in Pfizer's Exubera were ex-smokers. Mannkind did a far robust trials treating the technosphere as a new chemical entity.
What is really lost in this is the apparent need for a fast acting insulin that mimics the normal physiologic release of meal-time insulin. The existing rapid acting analogs (novolog, humalog etc) are woefully inadequate in fulfilling the role of a meal time insulin.
Some major drawbacks of rapid acting analogs in the market are
a) It is slow to peak (takes an hour to peak)
b) It stays in the body longer (upto 6 hours)
c) It fails to shut off hepatic glucose output (there by worsening the hyperglycemia)
d) It is harder to take correctional dose as one is staked on the other
e) Due to reasons a & c, it causes huge post prandial glucose excursions (PPG). PPG causes macrovascular complications, glucose toxicity, beta cell death etc
Both Linjeta and Afrezza have a better pharmacokinetic profile than RAA's and have done better in their trials with fewer hypos and less weight gain. The medical community and the diabetic populations recognize the need for a more faster acting prandial insulin. The Afrezza peaks even faster than Linjeta.
The FDA was slow the recognize the benefits of existing rapid acting analogs when it first approved them. FDA thought that the only advantage of RAA was that it can be taken at the time of meal ingestion as opposed to take it an hour before meals.
It is high time for FDA to acknowledge and approve the newer therapies. A delayed approval is almost a denied approval. If FDA keeps changing the rules of the game, it'll kill innovation.
Disclosure: Long MNKD, no position on Biodel
Why the world needs a Biodel & Mannkind?
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