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) 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): 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) (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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