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Re: boi568 post# 444245

Tuesday, 12/26/2023 8:22:07 PM

Tuesday, December 26, 2023 8:22:07 PM

Post# of 462173
You are making several assumptions in this statement that may or may not be true.
What Missling said was that the EMA has seen data that has not yet been published. Whether that is the "full" data or not is unknown.

Second, I doubt that the EMA did a technical review. The EMA has not appointed the subject matter experts yet. I get that that they do have staff people that are competent to look at what Anavex presented and understand what they are seeing. I doubt that the staff did a technical review in the sense of a deep dive into the data presented. More likely the staff looked at what Anavex presented decided that it looked reasonable and OK'd moving on to a MAA where a full technical review will take place. The staff may have even said this looks very good. Either way, it is the MAA process where the deep dive into the data takes place.

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