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The FDA decided last week to wait another four weeks before determining whether or not to approve Afrezza, an inhalable form of insulin that is being developed by Mannkind Corp. There’s some insightful analysis at DiabetesMine.com:
“… the drug’s safety record may not be as rock-solid as the company claims. Something you ought to know:
In October, former company executive John Arditi, once responsible for quality assurance, filed a lawsuit claiming that portions of MannKind’s clinical data were fraudulent (see details here). Although the suit was settled out of court last month, it’s still not clear whether Arditi was simply retaliating for what he believed to be wrongful termination, or whether he was pushed out for being a whistle-blower.
Seminal pharma blogger Ed Silverman of Pharmalot writes that the allegations “underscore ongoing concerns in some quarters … regarding clinical trials that are run in Russia and Eastern Europe. Arditi’s charges are likely to cement impressions that studies relying too heavily on data collected in such locations may be viewed as questionable.”
What’s interesting to me is that one story I read seems to be entirely coming from an investor’s point of view. David Whelan at Forbes says that the “FDA should let the market decide.” (Full article here.) The FDA generally does let the market decide, as long as the drug or device is safe and appropriate to use. In general, I’m hoping (and think its probably the case) that the FDA is doing everything it can not to care one iota about what investors want to happen.