BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

Don't be surprised if the meeting results in a recommendation to submit an NDA application addressing HSDD and CV with the intent of bringing them to market. Along with an agreement to conduct a phase IV trial for drug optimization.

PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

This trial can further narrow down the intent to treat optimal group for HSDD and examine additional criteria for CV (cholesterol reduction etc..)

Since testosterone is already being used off label, this would seem the most logical course of action.