Daviddal, Dr. Stoll may not give much additional info on the nature of the original histo finding, though I'd like a confirmation that it was seen in primates (I don't remember this being officially revealed, unless I missed it).
Some topics for the conf call include -
1) Details of the dose level restrictions.
2) Are there dosing duration restrictions also (specifically, is 3 week dosing allowed and at what dose?).
3) Did the new acute data that Cortex sent to the FDA appear clean (no apparent repeat of the histo finding)?
4) Was the current 3 month tox study in primates requested by the FDA, or was it a preemptive "just in case" suggestion by Cortex's consultants?
5) Is there any assurance from the FDA that getting clean 3 month primate tox data will remove the dosing restrictions?
6) Likewise, can we reasonably expect clean 3 month primate tox data to allow future 3 month human trials to proceed?
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