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.