As I have understood the PR from Anavex, yes. But many will argue that if the 7 week trial turn out astonishing results the bar is very low and may lead to conditional approval while an ongoing trial (P4) monitors the long term outcome in a larger cohort.
My guess remains that the PDD trial will be the first to give us a controlled view on how good A2-73 actually is.
I'm thinking they will do what they did with Alzheimer's - use the 7 week for data to inform the larger trial...
I do think a larger trial will be wanted, but if we have evidence of minimal (sleep only) efficacy in all three trials I do think the landscape of the follow up trials will change.
Three different jurisdictions making independent decisions, but looking at data from the extended Alzheimer's 2b and three different CNS trials.
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