1) During the clinical hold, CX717 couldnt be given to anyone. Now they can, so long as the work within the protocol of the AD trial.
2) They showed up (I believe he said) in the 14 day rat trial, but not the longer monkey trial. Which raises the question of a metabolite which is species-specific, and the earlier isolated monkey case being due to the procedure--since they didnt see it in the later monkeys.
3) Organon would have done tox studies at the dose level wherein that first monkey anomaly showed up--not the higher doses. I'd bet you that they've now run the higher doses on monkeys and/or rats with Org24448--and would have committed to telling Cortex if they found anything. Stoll made it clear they had not.
4) It is important to the FDA that they can't figure it out--it's like when the FDA complains that someone couldn't find a maximum tolerated dose, even if it means you can go sky high--they hate ambiguity.
5) I don't think Stoll has concluded that CX717 and ADHD arent going to happen--but it is possible, so he is already working on the backup. Also--one of the hottest maybe the hottest partnership proposal that was on the table last spring was for AD. Given that he can continue working in AD, and the safety bar for AD is lower than for ADHD, he's going to accentuate where he has some control.
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