We would be having none of these discussions if the P2b/3 trial had shown clear efficacy as per protocol and SAB priority incl. dose dependency. Instead we have massaged information and change of plans dripping out over a wait of more than 18 months by now since TLR.
It doesn't matter how hard you, or anyone, try to convince me by repeating the same Anavex unreliable information in this and that way. What I am saying is that full data analysis of the main trial against with correlations to genetic biomarkers in placebo vs. drug patients and then placebo patients on drug during OLE, may be helpful because it is objective even in a non RCT confirmatory trial scenario. Likely also what the KOL may have suggested to Missling.
That remains my opinion because I have seen, heard and understood the detail, which coupled with my experience in biotech investing has some relatively good (< 20%) chance of approval because of the unmet need and relatively good safety profile in AD patients. Even so I have hard time to imagine full approval, more likely some conditional and limited label approval with a follow on confirmatory trial - and yes I know what Anavex and Missling have said, but history shows that doesn't count for much.
Doc might be right about the 1% chance, but I am not that pessimistic if objective biomarker results supports the findings that Anavex are showing in completers only.
The longer we wait, the sooner we will get rich!
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