Neuro, Davidal, I assume all the required Phase 1 work has long been done for CX-717 (young and elderly), so Cortex could conceivably just file an IND with Neurology for a regular AD Phase 2? The trial could use cognitive/memory improvement as a primary endpoint, dose for say 6-8 weeks, enroll perhaps 50-100 patients. The wildcards would be getting Neurology to approve it, and then later finding a BP partner who's willing to take a chance on going further with CX-717 with the FDA. A backup compound could be included in the deal though, giving the BP a plan B in case the FDA balks at longer/larger trials with CX-717. In that case the CX-717 trial would have still given them a good read on POC.
There isn't much to lose by submitting an IND for such a trial to Neurology. All they can say is no. Or would some additional elderly Phase 1 work still need to be done first?
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