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iwfal

05/12/07 10:35 AM

#3495 RE: Gametheory101 #3491

This begs the question, just how beneficial might a fourth booster infusion be? If Dendreon is going to negotiate with the FDA to change the 9902B statistical plan to allow an earlier interim analysis, they should negotiate to allow a booster infusion for all Provenge patients still alive after 6 months.

A change in the clinical protocol (i.e. patients getting an additional shot) is not possible after the first patient is enrolled.