>The point I was trying to make is that it's quite possible that if it weren't for the 483, Provenge would have gotten approved by May 15th.<
Understood. I think your conjecture has merit, although it’s not clear to me why that matters now.
Assuming the FDA now requires that 9902b hit the interim or final survival endpoint set forth in the SPA, the criterion for the approve/no-approve decision is well-defined and there presumably is no “carryover” from the miss on the first review cycle.
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