Guest guest Posted January 4, 2011 Report Share Posted January 4, 2011 FDA oncology drug review panels consist of core members which are augmented by persons with specific disease knowledge. For CLL reviews seldom does one of the most famous experts serve on the panel because they have connections to drug companies which create a conflict of interest. These same experts are however represented at the sponsor presentation portion of the meeting (Kipps, Rai, O'Brien, Keating). I was the patient representative at the ofatumuab (Arzerra) meeting where I found the level of CLL clinical experience in the invited augmented panel members to be high. It should be noted that the vote was 10-3 in favor of the drug. Quote Link to comment Share on other sites More sharing options...
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