"SIGMAR1 being pre-specified doesn’t rescue a weak overall outcome". That is crap. Absolutely ridiculous. If the regulators adhere to that then they are crooks. There is absolutely no rationale to fail ABCLEAR1 by pointing to the ITT results. There might be if there were safety issues outside of ABCLEAR1, but there weren't. The negative trend vote might be just on ITT with Anavex insisting on ITT and not just ABCLEAR1 because the OLE was so convincing for the entire ITT, and they might be confident that they can persuade the CHMP to agree with further data/analysis from the OLE. Some of that data is brand new.
The pivotal ITT results certainly was robust enough and efficacy is better than all other approved therapies by a long mile. The WT result was pre-specified and outstandingly good. The COL24A1 WT result was indeed post hoc and should be confirmed subsequent to approval - but the AD WT pre-specified result (71% of AD patients) seeing 50% reduction in progression is amazing - and 37% overall progression reduction is also worthy of standard of care.
The only weakness is lack of a confirmatory trial. This is the only thing holding back outright approval by the EMA and holding back submission of an NDA to the FDA. This is my opinion.
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