Replies to post #16716 on BioSante Pharmaceuticals, Inc. (BPAX)

[Jeffqdh]

http://www.marketwatch.com/story/biosante-pharmaceuticals-announces-new-libigelr-phase-iii-efficacy-trials-2012-06-11

hope this helps ! They will examine the safety results 2nd quarter 2012 , now......my guess July or Aug .....End of year, 1st quarter of 2013 new efficacy trial...If all goes well, no delays , NDA possible next summer, early fall ? Not sure. Depends on how long the efficacy will be required to take.

Here is the good news, just my take. We will have safety results well before efficacy. With all the data there is out there to support efficacy, we should see a very strong interest from investors if/ upon safety approval. And yes, even after approval.....safety trial will run to 2016.

So, with the future of Libi now being determined......Safety looking good. Whats next?

My guess they partner sooner than later...Unless they have something else in store , I.E. Teva launching Bio T Gel....Or Licensing or partnering Gvax for one or all indications. This is a very smart management team...I assume they know there will have to be something to support, move the PPS now that Libi is moved out till next year ! All being said, today s news is spectacular.

GLTA

[nutsyprofessor]

Yes but the extended safety study period is POST approval. The portion of the safety study period to be used for the NDA submission ended on May 31st. Biosante is currently gathering the data and the analysis will be performed and the results communicated in a couple of months.