BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

Based on the definition as obtained from Clinicaltrials.gov, one would think when evaluating the overall benefit-risk relationship the CV benefit of the phase III trials should negate the placebo effect. Remember that Libigel was effective, it is just that the placebo was equally effective.

If the FDA views it as it reads in the definition, upon passing the next safety review Biosante should be in a position to make the New Drug Application for Libigel.

They can then follow it up with a Phase IV trial to focus on the optimal use. This will show which patients Libigel is best intended to treat. At this point Libigel will already be generating revenue

In addition in order to maximize the CV benefit another phase III or IV trial will probably be required to identify what are all the cardiovascular benefits (cholesterol reduction, etc...)

PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.

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

INTENT TO TREAT: Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized (See Randomization) even if they never received the treatment.