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kund

06/12/24 10:01 PM

#461040 RE: Steady_T #461039

It means Anavex is a black box and, as usual, and misleading is hiding crucial information. The street has no trust in the CEO and management; this company is run by crooks.
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nidan7500

06/13/24 8:48 AM

#461056 RE: Steady_T #461039

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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WilliamMunny

06/13/24 11:06 AM

#461070 RE: Steady_T #461039

Every month (excluding December, it seems) there is a submission deadline for rapporteur appointment requests, occurring in the first week or two of the month. Five or six weeks later the rapporteurs are appointed for all those who submitted requests since the previous deadline and who are no more than seven months from projected MAA submission on the rapporteur request deadline. For submissions by the January 10th deadline rapporteurs were theoretically appointed during the February 19th-22nd period. Similarly, submissions by February 7th generated appointment in mid-March.

Submission of the LOI does not start the rapporteur submission process. Request for rapporteur appointment can and often does come later, and, in my opinion, the "rapporteur appointment process" does not actually begin until one of those monthly submission deadlines, when work begins on that next batch of requests. Regardless, if Anavex was in the process though submission on the February 7th deadline (as suggested by Missling's comment), then the date seven months before the projected MAA filing occurred between January 11th (the day after the previous submission deadline) and February 7th.

This is my reading of the rules and procedures.