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  • jimbotool jimbotool Feb 14, 2013 1:25 PM Flag

    FDA Panel Vote Revisited

    The actual transcript of November 15th meeting is posted on fda.gov., all 177 pages of it,at page 170 the members who voted NO are asked to explain their reason. The first guy says he wanted a larger trial size of 8-10,000 patients, read how each one 'agrees' with whatever was said before them before adding their own comment(if any). Including the NO's who seemingly favored approval for the higher risk patients, to lessen safety issue. The very last comment came from Dr Gellin ,from CDC, IMO another 'SOFT'(see p.168) NO vote , I'm now quoting Gellin "we have to be realistic that if you double or triple the number in the trial you are STILL looking for rare things to happen, and they are unlikely to light up if you have a study population of eight, 10, 15 thousand, if you are looking for one in a million...........as we start looking at these new adjuvants there is going to be a lot of scrutiny about that experience. So that doesn't mean that we need to go slowly, but we need to go methodically." Reading that transcript, I found a lot more reasons in to believe.............in approval.

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