I haven't yet read the FDA Guidance article you linked to, but your post makes perfect sense. (For me it's reminiscent of thermodynamics aka "thermal and statistical physics")
(It may also help make sense of the P2b/3 data once we see it. And the nonlinearity Investor keeps referring to. It will be interesting to see if the biomarkers suffer less from that than the cognitive/functional outcome measures do.)
This also supports my notion* that Anavex likely concluded the FDA will want a confirmatory trial that's larger and longer than the P2b/3. More expensive, of course, but if we're already selling blarcamesine for Alzheimer's under AA, it's fine with me. :)
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