I have started differentiating between the CV and HSDD purposes to promote awareness.
Firstly, all that sits between applying for NDA approval on the CV benefit is the the results of the final independent Data Monitoring Committee (DMC) unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study. The previous seven reviews have passed without modification. And in the eight review the DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification, as there were no general or specific safety issues based on their unblinded review of adverse event. One would think that issues would have surface by now. (I believe this is now their biggest play and they are playing like an ace up their sleeve) They don't have a placebo effect to deal with as it kicked placebo's butt.
Secondly, Biosante will have to work a little harder to overcome the placebo effect in relation to HSDD. I believe the diary data that they have analyzed will negate the placebo effect and permit the NDA application to move forward. Interestingly, though this was the original intent of the Clinical trials and still remains highly lucrative, the CV benefits will prove the greatest money maker.
Thirdly, discussions with the FDA will identify the best way to submit the NDA. These discussions will determine if both CV and HSDD are covered under one NDA or if would they be better served under separate NDA submissions.
