Sorry for the delay answering X. I was at work yesterday and we were in the midst of a computer systems upgrade. I think news that they are not changing a thing for the confirmatory trial is driving this. The first trial protocol was unequivocally a success and I posted a long DD a couple of months back and will repost it later. Just a few points from it.
- 020 trial was designed only after ongoing consultation and input from the FDA. After blowing the first two trails ACAD's back was against the wall and they had to get this one right.
- adverse effects were minimal and infrequent.
- primavaserin addresses an indication that has no treatment presently. The potential market is >$1B. This is in non biologic where the COGS will be nominal and the margins (ex-amoritized R&D costs) greater then 95%. This is not a hyperbolic figure. Drugs like Zyprexa, Abiiify, Seroquel had >$1B each and were all competing against each other in the same space.
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