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Investor2014

02/06/24 2:49 PM

#451015 RE: Steady_T #451013

Agreed and the CHMP can't do that until the MAA is filed - agree?

Joseph_K

02/06/24 3:36 PM

#451027 RE: Steady_T #451013

I think it's ambiguous, though I lean toward Investor's interpretation. First of all, I regard "marketing authorisation applications" as specifically the MAAs, not some overall term for the entire centralized procedure process. Also, as Investor pointed out, the relevant webpages make no reference to CHMP until after the SOE and LOI have been filed. Then again, it doesn't specify what body in the EMA does review them.

I totally accept you wanting not to get in a pissing contest over this. Indeed, I appreciate it. :) There's nothing to be learned or gained from it at this point (which is usually the case).