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Re: Doc328 post# 445669

Thursday, 01/04/2024 12:41:35 PM

Thursday, January 04, 2024 12:41:35 PM

Post# of 462134
Hi Doc, thanks for the great posts. Your one of the only people I follow on this board as you have relevant scientific knowledge to the subject. Just want to confirm your insights into AD and RETT as I think you are interpreting. This is a real basic set of points

1. RETT adult data is likely not sufficient for approval without an additional study and if the pediatric data just presented was successful then that could have been enough but it was not and therefore RETT will likely need another study. 2-3 more years before approval if successful?
2. AD data was cherry picked but has hints that it works but not enough data was provided. With the data we have including the criss-cross graph, there is not enough for approval and another study is needed. Do we expect an AD study update at 96 weeks to see more compelling CDR-SB and other data? If so, would this be enough? If not an additional phase III would push approval to beyond 2026?
3. The December 19 "Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of an application" is nothing but a formality and means nothing regarding EMA accepting the data and results of AD studies.

I already sold after RETT data and wish I followed my instincts and sold 1/2 above 9. Part of my analyses included your insight which I should have put more stock into. Right now I am trying to think if reopening a small position after wash sell is worth it but not if no approval for 2 years or longer. Cash raise
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