If this dataset were as strong as you suggest, Anavex wouldn’t be sitting on a negative trend vote after a full oral explanation. What actually happened is much messier:
multiple endpoints,
multiple analysis populations,
shifting hierarchy,
“delayed start” / OLE tricks,
and heavy reliance on selected analyses, not the full, pre-planned ITT.
The core issue is simple: the pivotal ITT result was not robust enough, and regulators don’t approve Alzheimer drugs based on post-hoc genetics, post-hoc subgroups, or exploratory MRI correlations. SIGMAR1 being pre-specified doesn’t rescue a weak overall outcome, COL24A1/ABCLEAR3 remain post-hoc slices discovered after unblinding, and MRI volume even if pre-specified is not a validated surrogate for efficacy. CHMP saw all of this and still said no. That tells you everything about the credibility of these analyses. Sorry it sucks
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