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kund

08/11/24 3:39 PM

#467177 RE: 12x #467176

Another word salad from TGD? Completion was mentioned in last PR

Completed last patient last visit in the ATTENTION-AD open-label extension 96-week trial. Interim data expected in the second half of 2024.

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williamssc

08/11/24 4:43 PM

#467182 RE: 12x #467176

During the Q3 call, Dr Missling did report the OLE last patient last visit was completed in June, then went on to say interim data is expected in the second half of 2024. By the wording, Dr Missling et al. are waiting for those results. I too am wondering why Dr Missling didn't toot his horn louder or be more excited of upcoming interim. Not surprised though he's generally vague about most things.
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boi568

08/11/24 10:17 PM

#467203 RE: 12x #467176

If the FDA changes its guidelines regarding endpoints, the new guidance will govern FDA decision making at the approval/disapproval point -- i.e., at the end of its process. In this case, assuming an NDA, sometime in 2025. Not now, and not when the Anavex 2b/3 protocols were established years ago.