BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

FDA Regulatory Information on Off-Label Drugs

Off Label use of Marketed Drugs

Guidance for Institutional Review Boards and Clinical Investigators

Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects.

HSDD is an unmet need. Seeing that there was no distinguishable difference in relation to efficacy between Libigel and the placebo (subset analysis aside), both worked well. It is then reasonable to assume that the onus placed on physicians to justify the use of Off Label" drugs would be lifted through the approval of Libigel.

The compelling argument for FDA approval of Libigel would include the following:

- Safely filling an unmet need of treating HSDD.
- Reducing the onus on physician who feel compelled to write off label prescriptions as a treatment.
- Providing a proven safe method of testosterone replacement for post menopausal women.
- Providing another method to reduce cardiovascular events thereby saving lives.

Of course, this is based on the assumption that Libigel safety trials results will be consistent with the previous 8 evaluations.