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Just the facts maam

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Just the facts maam

Re: jadite post# 15961

Saturday, 06/02/2012 3:45:07 PM

Saturday, June 02, 2012 3:45:07 PM

Post# of 26138
Jadite, it appears that efficacy information where the FDA voted 14-3 in favor of the efficacy of Intrinsa could be used.

I have attached a power point look at pages 7 onward shed light on how 505(b)(2) NDA works.

NDA Process
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