BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

An excellent post from the Nutsyprofessor of the Yahoo BPAX message board. I only wish I could understand it all.

I HAVE THE ANSWER TO WHAT'S HAPPENING W/LIBIGEL!!!!

This is critical people but you have to follow me here and dig deep down into these details and try to follow along.

The first thing you need to do is to read the, "VALIDATION OF THE INVENTORY OF SEXUAL EVENTS AND DESIRE (ISED) DIARY", (see link); this is the whole key to what's going on between the BLOOM trials and this final extension trial and Simes comments that Biosante is reviewing in detail some data subsets and such.

VALIDATION OF THE INVENTORY OF SEXUAL EVENTS AND DESIRE

The key is that the women in the BLOOM trials were radomly assigned to the placebo and treatment arms, MEANING, they have NOT YET BEEN SEPERATED BETWEEN THOSE WITH HSDD AND THOSE W/OUT HSDD!!!! That was the whole purpose of using this FDA approved...VALIDATION OF THE INVENTORY OF SEXUAL EVENTS AND DESIRE (ISED) DIARY!!!! As you can see from the above link, this diary was tested and proved for this whole purpose:

""The BIOS-VAL-002 study was designed
to evaluate the Inventory of Sexual Events and Desire (ISED) event diary for discriminate validity between subjects
with HSDD and subjects without female sexual dysfunction (No FSD).""

So how does this now tie in with the final PH3 extension trial? SIMPLE: it's all in the EXCLUSION CRITERIA!!! As per the extension trial's indicated exclusion criteria: "Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator", this means that the trial investigators will now use the, "INVENTORY OF SEXUAL EVENTS AND DESIRE (ISED) DIARY"...to EXCLUDE the woman that have NO HSDD!!!! Once this is accomplished the placebo will no doubt show LESS efficacy than the treament arm!!! It's all very clear to me now how these series of trials are being conducted AND why this final extension trial is so important.

Trial extention

I am now more convienced than ever that LibiGel is still alive and well.