I still don't feel that flibanserin has a very good shot at approval. BI continues to use pooled phase III data whereas not all of the individual trials met their primary endpoints. And I assume that # of satisfying sexual events would be the crucial endpoint, seeing as how this is what FDA went with in SPA with BPAX. Also, it does not appear that the safety trial is nearly as rigourous- only measured 12 weeks on therapy. This wouldn't seem to meet the higher CV safety threshold. If we subscribe to your postulation that the FDA prep for this advisory committee meeting is what caused the increased requirement for BPAX, then the B-I safety trial looks even more unsatisfactory
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