RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

Dr. Stoll said that the new info had been sent to the FDA on Sept 8th, and that the FDA had received it on Sept 11th. So as I understand it, the FDA should give their decision within 30 days of Sept 11th. At the Roth Conf, Dr. Stoll said they should have a response by "mid-October, roughly speaking".

Concerning the "toast" scenario, if something really dire was readily apparent in the new results, Cortex would have almost certainly said something since it would have been material. A second possibility is that there may have been something abiguous seen in the results, not clearly dire but possibly not right, and Cortex submitted that ambiguous data to the FDA, not saying anything about the data publicly one way or the other. A third possibility is that the data looked totally clean to Cortex, but the FDA might want additional data/studies for some other reason. And a forth possibility is that the data looked totally clean, and the hold is lifted immediately.

Clinical holds are apparently not all that uncommon. When it happens to a big company, it's not necessarily considered "material" and the public never even hears about it. Microcaps often have everything riding on their lead compound, so the existence of the hold has to be made public.