Monday, March 26, 2012 12:47:26 PM
MAP hasn't exactly been projecting confidence in Levadex approval either. The company decided not to pre-build inventory prior to hearing from FDA; and the filing of its most recent 10-K was delayed last week for what the company claims is an accounting issue.
Then there's the mystery of the Special Protocol Assessment (SPA) for the sole phase III study conducted with Levadex. In the past, MAP claimed that FDA granted an SPA for the Levadex study, but more recently the company said that FDA had no record of an SPA. Weird.
I tried to get an explanation from MAP about the "missing" SPA but company executives declined to speak so close to the FDA's decision date.
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