Replies to post #14248 on BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

Further to the benefit-risk relationship. Upon reviewing the following;

A United States Regulator’s Perspective on Risk-Benefit Considerations

I found the following statement very intersting;

U.S. statutory standard does not require that a new therapeutic be superior to available choices, only that it be safe and effective for the intended use.

Since there is no FDA approved alternative to compare to, the placebo was used for the Bloom trials. Libigel was proven effectively on par with placebo and superior in safety to placebo.

What doctor would prescribe a placebo or an off label prescription if Libigel were available? They would just be increasing their liability.

I believe that if safety review is good, they have enough to file for NDA application. Biosante is now just trying to solidify their case by accounting for the placebo effect.