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Hoskuld

11/01/24 11:17 PM

#472901 RE: Cpap21 #472878

He doesn't have special knowledge. He is a smart guy but that doesn't really matter. The trial size, the number of trials, and the quality of the data and analysis - and the regulatory agencies willingness to overlook the shortcomings of Anavex's application (only one trial instead of 2 registrational trials, size of that trial) in favor of the quality of the data (effect on cognition and brain volume) and total lack of SAEs (pretty remarkable for an biologically active drug) - these are the variables that matter. CM and Anavex had the ability to eliminate the risk and they didn't do it, so now they depend on a little luck to supplement that positives about 2-73.