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Doktornolittle

05/24/16 11:45 AM

#62762 RE: notbrad #62760

Easier enrollment. That makes sense as a motivation for the sponsor, but I don't see why the FDA would have the right to impose crossover for that reason.

Recall that Dendreon did not initially get approval and was required to drag the trial out. Recall that it was believed that BP influence via one of the FDA members voting was responsible for that decision. Was that same BP Doctor responsible for the decision to have crossover?

People protested the snot out of that situation. If they hadn't, would Provenge ever have gained approval?