>The Cortex (COR) and Hemispherx (HEB) cases have nothing in common as far as I can tell. COR’s drug was in phase-2 when a tox problem showed up, and the FDA put the drug on clinical hold for the given indication (ADHD). What was unusual about this case was that the tox may have been an artifact of laboratory processing rather than a real pathology; however, in all other respects, this case was routine. <
I wasn't saying it was similar, I was saying that the fda is very concerned about this tox work even in early stage development and I used Cortex as an example of this. What I was saying was that the fda should not have accepted the nda filing at all.
You said you aren't sure it was accepted but I am 99 percent sure that it was. Carter keeps the con going by being very clever in the way he words his releases, but if he ever said the filing was accepted when it wasn't I believe the fda or sec would go after him. It isn't the same as getting a complete response letter and not reporting it, because since he never thought it would get approved, he can make the determination that, when it came it wasn't material. A ligitimate company wouldn't do that, but HEB would.
