Let the bureaucrats call the approval something else if they need to , because they failed to have the foresight to incorporate it into the original subpart H regulations , but we all know what it really is.
David is making a valid point - 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. The language of the approval, should that be the outcome, will be interesting.
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