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Re: poguemahone post# 461303

Saturday, 06/15/2024 3:10:47 PM

Saturday, June 15, 2024 3:10:47 PM

Post# of 470768
He said that they started the process in Europe because their process takes longer.

Starting the MAA process gave the company 7 months to work on the MAA once the LOI was submitted. In the US the process starts with the NDA submission.

The MAA and the NDA should both be ready for submission at about the same time or fairly close to the same time. The MAA process provides for meetings with the RA during the 7 months prior to obtain feedback and discuss potential issues before submission of the MAA. That feedback can be incorporated in to the NDA , improving it before submission to the FDA.

It appears that the EMA got to look at some of the data in making the centralized authorization procedure and the LOI acceptance decision. According to Missling, they liked what they saw and encouraged the company to proceed.

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