Thanks for sharing your thoughts and CCW example. So Anavex is in the pre-submission stage after being cleared by CHMP/EMA waiver to be eligible to submit an MAA. If the 7-month clock started last December PR, the MAA submission would be after June, which coincides with when the AD OLE TLR becomes available. Maybe this OLE can be used as a second confirmation trial as indicated by CM?
The way I understand is that there is no technical reason preventing Anavex from submitting an AD MAA other than the company's judgment call on how likely the MAA get approved based on communications with EMA personnel.
From Sep-23 PR, Jin is on board with "The trial is successful in meeting the co-primary endpoints".
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