$AGRX Ok THIS (page 7 of the 424B5) is what everyone is in a panic about??: "Following the BRUDAC meeting, the FDA had sent us a follow-up information request to which we are currently responding." REALLY?? How about the information before that which indicated: ... "FDA conducted a pre-approval inspection of our third-party manufacturer's, Corium International" ... "and held a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee, or BRUDAC" ... "to review the safety and efficacy of Twirla, which included a discussion regarding the Pearl Index, an efficacy measurement from our SECURE Phase 3 clinical trial that the FDA noted is substantially higher than other previously approved combined hormonal contraceptives. The BRUDAC voted 14 to 1, with 1 abstention, that the benefits of Twirla in the prevention of pregnancy outweigh the risks to support approval." After a meeting like that of course they would have questions.
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