Replies to post #20095 on RespireRx Pharmaceuticals Inc (RSPI)

[asuhowe]

thanks.

[RBlatch]

I think it will be the week of September 22nd.

Cordially,
RBlatch

[gfp927z]

Neuro, >>> they are not going to waste RD1 on a pre-Labor Day weekend release. <<<

Of course that assumes good results. If the results are murky or outright bad, then releasing them pre-Labor Day would be preferred.

We're less likely to have statistical significance in RD-1 for several reasons - 1) the lower dose used (1500 mg in RD-1 vrs 2100 mg in RD-2), and 2) the potential for procedural problems cropping up again, if not in the majority of subjects then in enough to prevent stat sig from being reached.

Without statistical significance in RD efficacy at 1500 mg, the press release will need to emphasize the good maintenance of analgesia seen in the subjects who did experience RD efficacy. That's the most likely outcome IMO -- no statistical significance in RD efficacy at 1500 mg (due to the dose being lower, procedural problems, or some combination), but good maint of analgesia in those who did show RD efficacy.

[gfp927z]

Neuro, If you're out there, here's a hypothetical -

We know that RD-1 dosing was completed prior to June 18. For arguments sake, let's say that procedural problems did occur in RD-1, but the DSMB wasn't aware of the problems until after the dosing was completed, and then it was too late to take any corrective action. Wouldn't the DSMB have still told Cortex about the problems they had detected?

Answering my own question - yes they would have notified Cortex. In that case, Stoll would have a pretty good idea that RD-1 was in serious trouble, especially after having seen what happened in RD-2 (ie - the same type procedural problems turning 2 cohorts into data 'mush'). That being the case, would Stoll actually say - "we do not have any insight into how the trial turned out at this time"? Stoll has always been a straight shooter, and I don't think he would have said that if the DSMB had told him 2-3 months ago they had found procedural problems in RD-1.