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crescentmotor

01/26/24 10:11 PM

#449634 RE: WilliamMunny #449623

it seems to me that what Missling said in the FQ4 conference call was a bit more than "is allowed to submit": "And we were from this meeting recommended to procede with this application, full approval application.



Yes but that gets into interpretation, which I try to avoid. The PR only speaks to an agreement for the eligibility for submission of an MAA. A legitimate question is just how much review was done by the CHMP and what exactly was said behind closed doors. I am almost certain that the discussions were more than "is allowed to submit" but that is unknown to us so I don't choose to interpret Missling's comments. That's my big grip with Missling. There is the statement "And that's what we proceeded with last week accordingly". This board contains a lot of posts trying to interpret what that really means and we just ended up with a lot of interpretations, none of which are provable without further clarification from AVXL.
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sumbuysumsell

01/26/24 10:26 PM

#449635 RE: WilliamMunny #449623

Thank you for this information. I would so love to be wrong. But in summary there doesn't seem to be anything in print and only a single verbal statement of a recommendation to proceed during Q&A for the quarterly cc.

Crescent, it seems to me that what Missling said in the FQ4 conference call was a bit more than "is allowed to submit": "And we were from this meeting recommended to procede with this application, full approval application. And that's what we proceeded with last week accordingly."



From the quarterly call:
At around the 2 minute mark there is a statement of submission
At around the 8 minute mark during Q&A there is a statement of several meetings and recommendation to proceed with the application
https://video.wixstatic.com/video/79bcf7_c8598d84565648258861db371a2527c6/720p/mp4/file.mp4
These are verbal statements behind Clints safe harbor statements.

Please note however there appears to be no reference to any of this in the 10-K filed 11/27/23 (7 days after the PR)
https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=317891180&type=PDF&symbol=AVXL&cdn=d7faa4749aef6c326a7afc083407e6e7&companyName=Anavex+Life+Sciences+Corp.&formType=10-K&formDescription=Annual+report+pursuant+to+Section+13+or+15%28d%29&dateFiled=2023-11-27