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Re: Jimbo50 post# 448254

Wednesday, 01/17/2024 11:14:48 PM

Wednesday, January 17, 2024 11:14:48 PM

Post# of 462737
I talked with IR this afternoon (approx. 30 mins) and had a very good discussion on various topics, including the antics of the organized collusive HFs (cabal).

The key takeaways on Rett were that they will be following up with the FDA with both the AVATAR and EXCELLENCE trial data, OLE and RWE data and results, pursuing approval. It was also conveyed how supportive the Rett Syndrome orgs have been and eager for blarcamesine to be approved. This should be a tremendous help for Anavex's cause.

Regarding AD, he would not elaborate on the timing of the MAA, but confirmed it's being diligently worked. I asked about requesting the 150-day accelerated assessment process and, though he wouldn't say explicitly, he reassured me that the team is on top of it. I asked about AU and UK, and his response was that EMA and FDA are their primary focus. He's very much looking forward to the peer-reviewed journal article being published, which will diffuse the organized naysayers. He couldn't confirm if it'll also include the PDD data or not, but would make sense if it did.

They're very excited with their developments to date (with more happening behind the scenes) and feel they're in a very good position to get to commercialization in a reasonable timeframe.
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