RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

Alertmeipp, It actually hasn't been established yet if the FDA requested the new 3 month tox trial. It sounds like Cortex and/or their consultants decided to start it on their own in the Summer, figuring (correctly it turned out) that the FDA might want still more data in the Fall (and a 3 month primate study was the obvious place to start). Whether this new 3 month data will be enough for the FDA to lift the dosing restrictions is another question - has Cortex gotten that in writing? Also, assuming a 3 week dosing duration is still currently allowed, at what dose level is it allowed? Obviously something like 200 mg BID for 3 weeks isn't going to cut it.

Then there's the question of Phase 2b type 3 month studies. Approval for this duration is likely out of the question without first getting the new 3 month primate data. And the FDA would have to approve not only the 3 month duration but also the desired dosing level (again, approving the longer duration but only at lower dose levels isn't going to help us).

Much of this should hopefully be clarified in tomorrow's conf call.