The four drugs approved by FDA -- from Amylin (AMLN), Vertex (VRTX), Roche- Curis (CRIS) and Teva (TEVA)- BioSante (BPAX) -- have been relative layups. The challenging drug approval decisions lie ahead, starting tomorrow with Corcept Therapeutics (CORT - Get Report) and its Korlym therapy for Cushing's Syndrome. This is where the contest should start to get interesting.
Forty-six percent of contestants are predicting an FDA rejection of Korlym versus 42% who are forecasting approval. The remaining 10% predict an FDA delay. Like I said, the Korlym approval decision is set for Friday.
Of the 23 contestants with perfect 4-0 records so far (I'm included in this illustrious group), 52% say Korlym gets rejected; 35% predict approval and 13% say no decision.Here's how the approval predictions play out for the remaining drug approval decisions: Columbia Labs (CBRX): Approval 5%; Rejection 88%; No decision 7%.
Discovery Labs (DSCO - Get Report): Approval 47%; Rejection 49%; No decision 3%.
Astex Pharma (ASTX): Approval 36%; Rejection 46%; No decision 18%.
NeurogesX (NSGX): Approval 47%; Rejection 46%; No decision 7%.
MAP Pharma (MAPP): Approval 37%; Rejection 59%; No decision 3%.
Affymax (AFFY): Approval 68%; Rejection 22%; No decision 10%.
Chelsea Therapeutics (CHTP): Approval 53%; Rejection 43%; No decision 3%.
Vivus (VVUS - Get Report) (Qnexa): Approval 49%; Rejection 39%; No decision 12%.
Amgen (AMGN): Approval 53%; Rejection 42%; No decision 5%.
Vivus (Avanafil): Approval 76%; Rejection 19%; No decision 5%.
Note: Cell Therapeutics (CTIC) was removed from the contest given the withdrawal of the pixantrone filing. One more note: One contestant has yet to get a single drug-approval decision correct. He/she is a lousy 0-4. I'll spare this person any further embarrassment by withholding their identity. --Written by Adam Feuerstein in Boston.
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