Replies to post #20044 on BioSante Pharmaceuticals, Inc. (BPAX)

[homeslice10]

Not only is your statement correct but Biosante proved that counseling works at 30,000 dollars per treatment patient. That's what you get into with FDA folks.

We still don't have much of an indication from the company that they are going to submit an NDA based upon CV and BC + safety data. In fact someone from the company said (donnenburg?) in a reported email on the board that they would not be submitting an NDA for this. And in Simes speech he indicated an SPA.

Due to the fact that all of this is going on and we know these people can't all be that stupid, there is clearly a bigger wheel that is getting these studies done (maybe a buyout suitor) and they are trying to keep this product low key through the approval process so that it can be assimilated quickly and inexpensively. That's the only thing that makes any sense to me.

[Just the facts maam]

I agree and there is no way that the counselling could be standardized so that each patient gets same consistent message. They would have to be given a pamphlet on the way out, no dialogue. As soon as there is interaction between the counselor and the patient the consistency of the trial is shot.

What the hell was FDA thinking?