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Re: porgyrusty post# 14747

Wednesday, 05/09/2012 5:42:42 PM

Wednesday, May 09, 2012 5:42:42 PM

Post# of 26138
There is a key word, many who are less familiar with the results of both the Bloom and Bliss trials are not aware of the importance of the word "and".

BioSante's corporate strategy always has included product development of high value medically-needed pharmaceutical products. In light of the top-line results from the two pivotal LibiGel Phase III efficacy trials, which indicated that LibiGel did not meet its co-primary or secondary endpoints, management continues to assess LibiGel's path forward and potential alternative strategies to utilize the continuing LibiGel Phase III cardiovascular events and breast cancer safety study.

Libigel is still being examined for HSDD, however should this fail they have enough data to submit an NDA to be used as the only proven safe low dose Testosterone Replacement Therapy for women (placebo can't do this). Since over 4 million off label scripts are written every year for male testosterone, what physician would prescribe male testosterone when a FDA approved product is available. Prescribe Libigel then they have reduced their liability.

The word AND (not or) indicates that they are referring to ability of Libigel to reduce the risk cardiovascular events by 71% for which Biosante has submitted patent applications.
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