Replies to post #44572 on Biotech Values

[DewDiligence]

>it isn't clear what the FDA's ability to repeal Provenge will be if it doesn't get p<0.05 on the Phase IV? This appears to be a gray area? Better than a true Accelerated Approval. Less final than with no mandated phase IV.<

Or they could simply issue an approvable letter and request that a CU program be set up until the results of 9902b are known.