The question which then occurs, but appears unanswerable, is what proportion of applicants receiving this warning just keep going for it and end up with a disapproval recommendation. I don't think Anavex is in that group, given Mayo's observations, but it can't be that many given the EMA stats on the high ratio of withdrawals to disapprovals.
I do think that if Anavex has just received an LoOI they are incentivized for a quick response. It would be great timing for them if they had an approval recommendation in hand by the time they arrive in San Diego for CTAD December 1 through 4.
It also seems to me that the MAA timing, the CNPV timing, and the 3-71 top line readout are all dramatically converging in the same narrow window of October-November.
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