I don't know how many days Anavex has taken in clock stop two. If they took all 30 days, then there is a good chance a November 13 opinion is off the table. But if they responded to CHMP by October 14, only about four days early, then they will have forced a November opinion timeline; October 14 is a full 30 days before November 13.
The company has incentives to do this. First, responding a few days early in clock stop two would accelerate any European Commission approval by a full month; second, it would give Anavex the ability to attend CTAD (Dec 1-4 this year) with a great deal of favorable attention.
We already have a strong signal that Anavex will have the EMA opinion by CTAD during the first days of December. On October 8, a TTT graphic was posted on Stocktwits that listed a scheduled Sabbagh CTAD poster appearance together with the comment "Potential for additional presentation/participation. Should know more by mid-Oct." (Again, the deadline for Anavex forcing a November CHMP opinion would be October 14.)
We just learned on October 23 that the final CTAD conference schedule now shows Sabbagh and Gabelle making "Late Breaking Oral Presentation" along with two posters and a Biotech Showcase.
Yes, I am connecting dots, but these are not imaginary dots and they lay close to one another. The most obvious interpretation here is that Anavex was working toward providing CHMP with a clock stop two response by October 14, they met that self-imposed deadline, and they then informed CTAD they had a late breaking development to discuss.
This timing points directly to a company expectation of receiving a positive EMA opinion on November 13. I expect we will find blarcamesine listed for an opinion on the CHMP meeting agenda two weeks from today.
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