RE:Some Facts zakmirza wrote: Historically FDA has approved a product 85% of the time when the Adcomm has been a yes. The FDA has rejected approval 86% of the time when the Adcomm is negative. Hmm! I feel approval is a toss up however. If Valstar with 10% success can get approved, MCNA with 25% success and significantly better safety and tolerability should be approved. Something, Adcomms this large are not common.
In the interest of accuracy, a slight correction. Between 2000-2010 the FDA approved NDA/BLA 88%(not 85%) when the panel has voted yes, coversely rejected it 86% of the time when the vote has been negative. Can we say approximately 15% chance of approval on Feb/27?