Replies to post #95992 on Biotech Values

[DewDiligence]

BPAX:

If we subscribe to your postulation that the FDA prep for [the flibanserin] advisory committee meeting is what caused the increased requirement for BPAX, then the B-I safety trial looks even more unsatisfactory.

My comment re the flibanserin advisory panel was a wild guess in an attempt to answer the question you posed about the reason for upsizing the LibiGel safety trials; I don’t actually think it’s likely that the flibanserin advisory panel was the reason for the change, but I don’t have a better explanation handy.

In any case, I respectfully disagree with your contention that the flibanserin safety database is lacking. Insofar as the two drugs could scarcely be more different, what the FDA wants to ensure the safety of LibiGel is not a good guidepost for what the FDA wants to ensure the safety of flibanserin.

[DewDiligence]

FDA briefing docs for Flibanserin in female hypoactive-sexual-desire disorder (for Friday’s advisory panel):
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM215437.pdf

BI’s own presentation:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM215438.pdf

FDA’s proposed questions for the panel:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM215440.pdf

On first glance, the FDA does not appear to be impressed by the data.