RE:RE:RE:RE:RE:We shouldn't be in this positionMy own opinion is that you send your heavyweights to a decision of this magnitude. For posture and humanizing the efforts of the company if nothing else. I learned long ago that big shots like to be sold to by bigshots. .
O'Donnel was compelling but I'm not sure that he was familiar with the insignificant mechanics of the trial that Adcomm members spent more than half their energy on. That is before proceeding to discuss the need for a comparative arm, in any trial looking to replace BCG ( some seemed to think this would replace BCG or somehow compete with it and cost lives???WTF?). A comparative arm that wasn't and isn't required. We can agree to disagree I guess. Either way the entire discussion and unfortunate decision had very little to do with the segment MCNA was intended to serve or its merits as a treatment and how they meshed with the FDA's own standards for approval.