Hosai, check under Section 2.4.1.1: Requesting the appointment of CHMP/PRAC/CAT rapporteurs/(co-)rapporteurs and their assessment teams
"We advise applicants to notify the EMA of their intent to submit and request assignment of (co-) rapporteurs seven months prior to the intended submission date. Although applicants may submit the letter of intent earlier than seven months prior to the intended submission date, the (co-)rapporteurs appointment procedure will not be initiated prior to that date."
On March 4th at the TD Cowen Conference Missling said that they were in the rapporteur application process and were awaiting notification of rapporteurs. Submission deadlines for the rapporteur appointment requests in 2024 prior to 4 March were on 10 January and next on 7 February. (There was no submission date in December of 2023.) If Anavex hit the January filing deadline, appointments were to be made by 19-22 February, so the notification was more than a week overdue. That, I suppose, was possible, but more conservatively I would presume that they filed by the February date. Worst case, if they filed on that date, the projected MAA submission would have been 7 September. Yes, it could happen earlier in the quarter if they submitted by 10 January and the EMA was late in responding. We do know, however that they didn't file for rapporteur appointment in November or December of 2023, so a Q2 2024 MAA submission was/is out of the question. Looks to me like mid/late August or the first week of September. Hope all this was reasonably clear and helpful.
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