Replies to post #82413 on Biotech Values

[DewDiligence]

HEB:

You said you aren't sure [the Ampligen NDA] was accepted but I am 99 percent sure that it was.

I said I was not 100% certain the NDA was accepted, so we are in agreement. With any other company, we would be 100% certain.

[gfp927z]

Drbio45, >>> What I was saying was that the fda should not have accepted the nda filing at all. <<<


In Cortex's case, the FDA was correct in accepting the NDA for Phase 1 and the Phase 2a studies, since the shorter term animal tox data supporting those trials was clean.

The tox problem only occured in a longer term 3 month dosing animal tox study, which was submitted to support Cortex's proposed Phase 2b. That was the stage where the FDA appropriately red-flagged Cortex's drug.