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crescentmotor

01/28/24 10:49 PM

#449962 RE: XenaLives #449953

I don't see where they announced any "hard cold details" of the EU discussions either.



That would be because SAVA's Phase III trials are ongoing and will both complete by the end of 2024. There is nothing to discuss with ROW regulatory authorities until then. The only discussions earlier were with the FDA, who provided input on the trial design, especially the CMS portion. Almost all of SAVA's trial sites are situated in the U.S. and Canada with a few scattered among Korea and Australia. None are in Europe.

Steady_T

01/28/24 11:17 PM

#449975 RE: XenaLives #449953

Actually they did. The EMA approved 2-73 for the centralized approval path which is a necessary first step in the overall approval process.
If that was not approved it would be game over for AD in the EU.