Maybe a RCT P3 seems overkill, but the key issue is that Anavex have not provided complete data from a P3 trial with the MAA filing. Instead incomplete data from a too short what turned out to be a P2 trial within which subgroup hypothesis have been generated and OLE data supplemented showing great promise, but not established per protocol proof. That is not what full approvals are made of and we plus Mayo and more are being to agree.
Anavex were clearly aware of this fact over 2 years ago, when they said they planned to run a confirmatory trial in parallel with investigating regulatory approval paths - they didn’t!
I don’t see why EMA should or would set a new precedent for AD trials of lower burden of proof. In oncology especially we are dealing with otherwise functioning and often younger patients with poor prognosis for life beyond months, where time is critical and burden of proof can be lower regarding making Type 1 error decisions.
Let’s see most likely in November.
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