The EMA's 210 days deadline is rapidly arriving. Anavex met its 90 day clock stop 1 deadline on July 21. The EMA apparently met its 60 day response deadline because it listed a recommended LoI for Anavex on the CHMP's September agenda. That brings the agency's daily count to almost 180 used out of its up to 210 day total.
Anavex presumably got no more than its official 30 days from September 19 to use clock stop 2 (since no extension of their time has been noted by CHMP).
So as of September 19, Anavex had no more than 30 days to use, as did CHMP on its end. The EMA MAA committee meets monthly and only takes action at its meetings, so there's no such thing as a CHMP deadline being met between meeting dates. If you go out 60 days from September 19, that lands on November 18, a few days *after* that monthly CHMP meeting. If Anavex has been timely during clock stop 2, as it appears, CHMP has to act in the November meeting to meet its final deadline.
It's possible that CHMP would be entitled to some grace due to being forced to choose between using a few days less than its allotted 210 versus missing the November meeting and being late to its decision. In that case, Anavex could still have forced a November EMA vote by not having used all of its 30 days during the second clock stop.
If the company expects a positive EMA opinion, which seems obvious by now, they would want it done in November to give them bragging rights for CTAD on December 1-4, as well as accelerating an eventual market entry in 2026.
November is therefore more likely than December, and it would be surprising if the EMA didn't issue an opinion this calendar year, since we have seen no indications of a delayed MAA process for blarcamesine.
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