At this meeting, the FDA did not ask the Committee to vote on whether to recommend approval of drisapersen but to vote on whether key aspects of the data strengthen, weaken, or have no effect on the interpretation of the clinical results. The Agency also asked the Committee to discuss the overall strengths and weaknesses of the data for the proposed indication, in a ninth question that was added on the day of the meeting.
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Earlier Event: November 19Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC)
Later Event: December 1Psychopharmacologic Drugs Advisory Committee