Some Facts 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.