RespireRx Pharmaceuticals Inc (fka RSPI)

[neuroinv]

There is no dose limitation--or should I say, nothing different from what every other investigational drug has, which includes limits on dose and duration predicated upon the animal data. Cortex does not appear to expect one, otherwise the IND and protocol they are preparing would be moot. The expectation is that the dosing permitted for the AD trial by Neurology, which fits what Cortex needs for ADHD, is the most likely predictor of what Psychiatry will go for in an IND. Gfp has raised the valid question of whether the duration of dosing might present a problem. I don't believe so, the duration limits will be based on the length of preclinical studies done, which go out three months or so--the human limit will be somewhat less than that--and Psychiatry will decide how much less. (Best case 8 weeks, worst case 4 weeks, and even four weeks would give them room for a Phase IIb. Six weeks is my guess).

The unknowns are: Might Neurology come back with some other issue, some red flag? If they thought it was likely, they wouldnt have given the OK for the dose-lifting. But--it isn't over til it's over. Similarly, while there are good reasons to think that Psychiatry will emulate Neurology, as I discussed previously; they don't have to. So there is an unknown element in Psychiatry's response as well. Given the shock to the system that Cortex observers experienced twice last year, first with the hold, then with the continuing dose limits, no one will relax 100% until the ADHD IND is accepted.

NeuroInvestment