Absolutely agreeing, but a couple of things: Wouldn't it make more sense for Anavex to wait to negotiate the proper confirmatory trial design after the decisions are made? They have been jerked around in the past by regulators regarding proper trial design, so wouldn't they want regulator input? Further, there is still data analysis going on. Anavex is still learning how to view all this through the regulator's eyes. And the regulators are still learning and have opened the window for new data or analysis. So wouldn't it make sense for both Anavex and the regulators to digest all the data and see eye to eye on the analysis before negotiating any confirmatory trial design? I believe Anavex has expressed their willingness to conduct a confirmatory trial. I would think that would be sufficient at this point. Another only semi related point is regarding the efficacy thresholds, the alpha values (which I often refer to as the p value requirements). My understanding is that the factor of 2 hit for that threshold, from .05 to .025 is based on the fact that they have two different dose subgroups. I don't know if they have to take that hit for the combined dose population, but I think so. What occurs to me is that this is something that would be expected to be resolved in any confirmatory, and so the multiplicity hit (in p value threshold) would go away. Both doses showed efficacy and safety, and it would be easy to justify a dose schedule for 30mg, 40mg, and 50 mg based on body weight or that surface area metric that estimates base metabolism. Since everyone would be in the safe and efficacious range of 30 to 50 mg, this would all be ok, and would likely generate a better outcome with a required efficacy threshold that is a factor of 2 less strict than the current threshold of .025. I believe this is clear. So how could regulators ignore this very large positive in the projected real world results following an approval whether that be for ITT or for just the ABCLEAR1 populations?
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