Replies to post #15961 on BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

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