@Doc328@Investor2014@frrol@kund Does the AD Phase 2b/3 full readout change your opinion on the EMA and NDA approval? Unless the AD OLE results are disastrous, Full regulatory submission of blarcamesine in Europe (EMA) is expected in Q4 2024. There was an 83% approval rate once submitted. FDA would be more challenging for the following reasons I see: 1. There is virtually no ethnic diversity in the trial. All white populations, nearly no representation from Black, Asian, Hispanic is a red flag for FDA and Asian countries to approve. 2. The dropout rate is too high. 335 patients dosed, only 191 completed. (107 in 30mg and 84 in 50mg cohort). 31% and 42% of 30mg and 50mg dropped out of the trial even with an Early Discontinuation statement. There is no evidence that early discontinuation introduced a bias in favor of blarcamesine How does one know the patients who dropped out would have worse than placebo ADAS-COG13 results?
Overall, it's a positive development as the dose dependency is somewhat confirmed. I see 12x the current price $80 which gives $6 Billion, about 1/3 of addressable EU AD market.
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