There were four MAA withdrawals reported this month, varying in time from July 22 to September 12. The withdrawals all occurred when the applicants chose not to respond to the List of Questions.
In each case, the EMA noted that they had told the applicant that its "provisional opinion was the [the drug] could not have been authorised." That's a bit more than just a list of questions, that's a tolling of the bell for the MAA.
I want to point out that Anavex received its LoQ on July 21, and several days later at the AAIC conference Mayomobile was enthusiastically told by several Anavex staff, notably Marwan Sabbagh, that the MAA process was going great. In context, this is highly encouraging; it appears there were no show stoppers in the LoQ. And since the LoOI will have built off the LoQ, I highly doubt there is a showstopper in there, either.
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