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Re: neuroinv post# 1358

Tuesday, 10/10/2006 12:19:55 AM

Tuesday, October 10, 2006 12:19:55 AM

Post# of 49891
Neuro, Without my detailed notes I'm having to rely on memory, but wasn't the histo "finding" seen in primates (acute short term primate tox data)? Also relying on memory, the original 3 month tox study was done on dogs and rats (not primates). So the FDA now logically wants to see longer term 3 month PRIMATE tox data.

The original 3 month tox study (the results of which were supposedly not a factor in the clinical hold), were needed in order to do longer term Phase 2b type studies. So it seems unlikely that the FDA will approve a Phase 2b IND before seeing the results of this new 3 month tox trial.

Dr. Stoll never told us that they were doing additional 3 month tox studies. As you said, these were probably (wisely) recommended by the consultants hired by Cortex to help deal with the FDA.

The conf call should be very interesting.
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