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nidan7500

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nidan7500

Re: Steady_T post# 461039

Thursday, 06/13/2024 8:48:19 AM

Thursday, June 13, 2024 8:48:19 AM

Post# of 517313
Steady_T...

The Letter of Intent (LOI) specifies an expected date for the submission of the MAA package. It must be at least 7 months post LOI submission date. Submission of the LOI starts the Rapporteurs appointment process. What has not been mentioned is that the EMA encourages meetings during the process, starting even before the LOI submission and afterwards.



Is there any evidence that these EMA meetings have happened? Is FDA participating?
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