only the Sigma-1R data has some validity to limit prescriptions (MMSE<20 already would have been an exclusion regardless of CMA or Full) . So a CMA might require S1R testing (swab or blood- not standard test but Anavex could have a large lab set up this test) which would allow 70% or so to get on drug. Hard to know what they would want for additional study as open label for efficacy loses much value and safety is not an issue. No MRI or lab monitoring would be needed if approved in any fashion. I still feel CMA or Full approval unlikely without additional true P3 (i.e 18 months and 700-800 patients randomized placebo controlled)
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