Sab, I don't think that ADL is the issue. I think the issue is that the P3 trial was small and there was no confirmatory trial done. This was the primary risk, one that I voiced for the last 3 years, and I think it came home to roost. I don't know if that is overcome-able but maybe someone will ask on Tuesday and discover if this was indeed the primary issue and whether the company can actually address it with the committee during the appeals process.
This is, IMO, the #1 things that Anavex needs to show the market now: can it run well-designed trials of the appropriate size and will they stop trying to cut corners and instead de-risk their programs. The behavior has been baffling: you have the ability to bring new standard-of-care therapeutics to huge markets and but you take ridiculous risks instead of spending money to make the path forward risk-free and extremely high return. I don't get it.
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