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Investor2014

02/06/24 1:31 PM

#450995 RE: Joseph_K #450991

Anavex to our knowledge have not yet filed the MAA. The CHMP is the relatively small expert team of the EMA assigned to evaluate the MAA starting at Day-1 of the process with validating the application for completeness.

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.

Anavex Received Agreement from the Committee for Medicinal Products for Human Use (CHMP)


I don't understand why Anavex in their PR references the CHMP as having agreed to the centralised procedure, I can only assume that is a clerical error in the PR.

My assumption has to be that the MAA hasn't been secretly filed, validated and now beyond Day-1 of the process with "CHMP rapporteur’s and co-rapporteur’s teams assess the evidence provided on the medicine and independently prepare their assessment reports (AR)".