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Re: iclight post# 17585

Tuesday, 06/26/2012 4:53:22 PM

Tuesday, June 26, 2012 4:53:22 PM

Post# of 26138
Iclight, I strongly believe the efficacy portion of the Libigel safety trial as it relates to CV events will produce enough data to support the submission of an NDA for the treatment of Hypertension and Dyslipidemia. The sample size in these groups are approximately three times as big as many cardiovascular related efficacy trials. The data will also be used to support Libigel as a HRT for post menopausal women. Which in the end takes care of the off label prescription issue (which is not strictly limited to HSDD, osteoporosis, muscle loss etc...)

The continued safety trial and post marketing studies will provide sufficient evidence to expand the use to treat Diabetes.

This fall Biosante will be receiving the results of the cognitive study in Australia. If all goes well I expect them to start a Libigel phase II cognitive study in addition to the phase III HSDD trials in 2013.

Shifting the focus from HSDD to CV is the proper strategy and i would question a company that put HSDD a head of the discovery of Testosterone on CV events.

If I am correct this is the best course of action. In all likely hood they already have a partner and this strategy is preventing them from buying more shares.


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