pete, we were lead to believe that the OLE data and other new data assembled would be allowed to be presented in the re-exam process. That was not true and caused many, including me, to have false hopes. If they knew it would not be accepted, then Anavex should have waited.
The filing last year was a "Hail Mary" pass, not a strong data set that it was claimed to be. My impression is that both sets of CHMP reviewers did not believe the numbers. Why else would Missling's last ditch appeal of a 10mg of blarcamesine add-on not be accepted, when there is NO risk involved at that dose!!
As to the fda, we have had many statements over 10 years about conversations with it, but still NOTHING!
Most of the people here, including me, wants to see the voucher and would sign up to get Blarcamesine as quickly as possible. But the old adage, "I'll believe it when I see it," is still apropos here.
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