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Tuesday, February 06, 2024 2:16:24 PM
The LOI must have been filed with EMA, as we appear to agree several months ago, who then recommended filing a MAA for the centralised procedure.
As to (2), I've recently pointed out its unfortunate ambiguity. As to (1), I, like you, don't see CHMP involved before the MAA is filed (but I'm judging only from the two webpages I've relied upon for the EMA centralized procedure). It's plausible to me that CHMP is involved in evaluating the Submission of Eligibility and that those webpages don't reflect it*, but you say it isn't. If CHMP was not involved, "clerical error" is a gross understatement; it's not like a secretary accidentally added it. I'm displeased by the lack of clarity in the PR.
* The EMA possibly omitting when CHMP first gets involved is very different from it failing to list a submission required of the applicant. The overall purpose of the EMA webpage is to provide the applicant with a summary guide of what it needs to do. Whether or not it's the CHMP or some other body that reviews the SOE is not critical information.
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