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Investor2014

02/21/24 2:08 AM

#452341 RE: williamssc #452340

If taking what Missling says literally, yes it does appear the MAA submission was initiated a week prior to the CC.

What exactly Missling means by “initiated”some Anavex investors have learned to question. Perhaps it means receiving further guidance under pre-submissions meetings, as submissions is binary event on scheduled EMA data slots that ensures CHMP Reporteur availability.

The full data behind the peer reviewed article that Missling said had been shared with the EMA was the reason for the full approval pathway. So I imagine that could take several pre-submission meetings to present that data as required for a MAA.