BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

First they must get the safety study completed around the end of May. Before they can get approved a NDA submission must be completed. Then I believe the FDA has up to 10 month to make a decision. This is the PDUFA date you see. Who will make the submission and take care of the regulatory hurdles remains to be seen. Will it be a partner or will Biosante take it to the end. They have talked about a cash runway? Was this the reason?

My research confirms what Nutsyprofessor has said all along. Biosante can use Intrinsa research data along with all the other data that confirms the relationship between elevated testosterone levels and improvement of HSDD. This should counter the neutral efficacy results between Libigel and the placebo. If not then a more stringent trial could be done with the target audience being the focus. The Bloom trials was very broad and had many participants for which Libigel was not the intended audience.

There is still the issue of such an elevated result from the placebo. I am not exactly convinced it was the placebo alone that did so well, possibly the combination of the placebo along with the diary log and the regular clinical visits caused the elevated results. Remember this was the only subjective variable being measured, the rest were objective.

No doubt the discussion with FDA will revolve around proceeding with the evidence of CV benefits.

Bottom line approval (PDUFA Date) is probably in early to mid 2013 unless a further trial is required to confirm the target audience(s) Then you can tack on up to an additional 6 month.