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Re: neuroinv post# 2259

Wednesday, 11/22/2006 12:27:55 PM

Wednesday, November 22, 2006 12:27:55 PM

Post# of 50057
Neuro, Trying to extrapolate human dosing from animal models can be way off. I remember Dr. Stoll once estimating that based on animal models, for cognition/memory we would likely never need to go over the 100 mg level in humans. Then in a subsequent presentation it went up to 200 mg. Next thing you know we were dosing at 1000 mg (and still not getting a good response, at least in the DARPA study).

Piros asked Dr. Stoll to give a rough idea of the human dose currently allowed under the FDA's restictions, but Stoll wouldn't do it. That non-response leaves us and Wall St totally in the dark, and gives the impression, rightly or wrongly, that the level is probably very low. I wouldn't be surprised if for a one time single dose type study (the PET study), they can still dose at 1000 mg, but for any study of duration (1 month or more), the allowed dose is probably 200 mg or less. 200 mg is not going to get us a good BP deal for any indication (IMO), which may explain why Dr. Stoll didn't want to reveal the actual dosing limitations. His refusal at least gives that impression.


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