Questions for Biosante
FYI
These are the questions being posed by the Nutsyprofessor of Yahoo board to the company.
Jeff, here are my final questions. Note that I also revised the efficacy data from the Safety trial question as well. The more important question is really with regards to what the FDA can or is willing to do and not necessarily what BioSante can do.
1) Can the FDA use efficacy data from the Safety trial if it chooses?
2) Given that LibiGel was specifically developed for women w/HSDD, why did the BLOOM trials include women with and w/out HSDD? Did BioSante specifically stratify non-FSD women to ensure equal distribution across both the LibiGel and placebo arms?
3) With regards to question #2, if this was an FDA SPA requirement, was there any concerns that the non-FSD women could throw off the efficacy results; especially due to higher variability in the average # of SSE's of non-FSD women? If so, was there any discussions about a solution to get around this issue?
4) With regards to the current LibiGel extension trial (NCT01235754); when does BioSante anticipate having results?
5) It is known that testosterone levels drop back to baseline levels within 24 hrs after stopping testosterone treatment, so what is the real purpose of this 12-week extension trial? Meaning, why would BioSante want to evaluate the persistence of benefit of LibiGel if testosterone levels are back to baseline levels?
6) The BioSante 2011 10K filing indicates that there is an SPA for naturally-induced menopause indication; how and when does BioSante intend on obtaining efficacy data for the naturally-induced menopausal indication?
Jeff, please send these to Mr. Doomberg as written and let's see if he responds. I don't really have high hopes that he would directly answer these questions.
Thanks
Hope he gets a response of value. Regardless,I will keep you all posted.
