In December of last year Anavex got approval to use the centralized procedure. There are no submissions taken for Rapporteur appointment in the month of December (and it would have been too late anyway at that point). Perhaps because of the scant time and end of year issues, they didn't hit the early January (6th?) deadline, but did submit for the rapporteur process in the February (the 12th) opening, which was the next available. That much we know for certain, given Missling's remarks on March 4th. That filing date means the actual MAA submission was projected for 6-7 months later. That means mid-August to mid-September. Had the company not asked for an extension during the window in June-July (which they surely must have), they could have gotten the MAA filled by the end of Q3. So, with an extension of a couple of months or so (which is very common), they plan to file in Q4. All in all, it is hard to criticize their level of promptness. Don't just think about the number of months, Bourbon, but think about the process the EMA has laid out. Between the initial filings, the wait for rapporteur assignment, the useful interaction with the rapporteurs, and the compilation of the massive document(s), it takes a lot of time for any filer. Getting the MAA submitted in the October/November time frame would get a good grade for any moderate or smaller company that first got the OK in mid-December of the prior year.
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