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BioSante Pharmaceuticals, Inc. (BPAX)
NSP, JTFM is exactly right. It's already been
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Saturday, June 09, 2012 8:55:04 PM
NSP, JTFM is exactly right. It's already been proven time and time again that testosterone treatments for menopausal women with HSDD works!
Here's just one trial example proving that the treatment works:
Many many more trials have achieved the same results and in fact, Intrinsa is already approved in Europe.
Frankly, the FDA is behind the times when it comes to this conditiona and this treatment! But many believe the time is now ripe and that the FDA is poised to approve a testosterone treatment for women with HSDD in the US. Biosante's Libigel is the only product that has done (is working) on the extensive safety trial that the FDA requires.
Unfortunately, something unexplained happened with the Placebo in the BLOOM efficaqcy trials. It's not that Libigel didn't work; it did and in fact it worked exactly as it was supposed to and just like in the past Phase 2 trials. The problem was that some how that Placebo worked as well. Meaning, the Placebo in this series of trials worked just like the treatment and whereas in the past, the placebo never had these kinds of test results.
I don't want to sound like a conspiracy theorist but it's almost as if the BLOOM trials were sabotaged.
Let's not also forget that Biosante also has a SPA for naturally-menopausal women and as we all know, the BioSante LibiGel Safety Study (BLISS) also includes naturally-menopausal as well as surgically-menopausal women AND more importantly, the BLISS study is designed/classified as SAFETY and EFFICACY study!
By the way, it appears that Libigel may also be under the oversight of Health Canada, in addition to the FDA. There might be a possiblity that Biosante is also planning to file for approval in Canada as well.
So again, let's just sit back, relax and wait and see what the company says about Libigel in the next 1-2 weeks...I'm sure it's going to be MAJOR news!
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