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Tuesday, January 02, 2024 4:54:04 AM
Although I am not known here as part of the WGT crowd, I believe the LOI was filed a good while ago and the PR with the CHMP go-ahead on filing through the centralised procedure was the culmination of most of the Pre-Submission actions. That is after completing line 3 in the table below.
My expectation is that Anavex are now doing the final "Pre-submission meetings (recommended)" and/or "Re-confirmation of submission date - before submission", in which case we may be a couple of months from the MAA filing.
EU Regulatory procedures for a marketing authorisation (MA)
The longer we wait, the sooner we will get rich!
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