Replies to post #474781 on Anavex Life Sciences Corp (AVXL)

[BIOChecker4]

Two words: good luck.

[frrol]

The MAA submission is not a FY 2024 event and will not delay the 10K, which has been extended in the last few years. We'll hear about the MAA when it's successfully submitted and accepted by the EMA.

Acceptance has taken somewhat longer than the company expected, as we are over the 7 month minimum. Hopefully it is not a matter of critical data availability. We should hear one way or the other soon.

[powerwalker]

This will be a critical test for the new management team

This is NOT a new management team. It is a management team that has some new members: Jin and Goldberger have been around for two years, either as EE or contractor, so I would not call them new. This is Dr. Missling's management team as it has been for 11+ years, regardless of whom comprises it.

[Bourbon_on_my_cornflakes]

With 18 workdays left in the year, it seems unlikely that any of the H2 deliverables will be met, aside from the confirmed MAA filing (per Dr. Lopez-Talavera in the PR)

No surprise there from the glacial AVXL mgt team, who fails to meet their own milestones more regularly than a Swiss watch.

The real surprise would be if Lopez -Talavera is right and the MMA actually gets filed.

That is the only milestone that matters, but we would be lucky if it is filed Feb'ish.

[kund]

Nothing will be achieved this year—it's the same story, year after year. This CEO is hot air, slogans and buzzwords. He can't execute, extremely incompetent management team.

[12x]

Congrats to Team Anavex for achieving this critical milestone on time! The expanded leadership team is executing exceptionally well.

Next up: OLE interim results, which will likely give us a clearer picture of the MAA's approval prospects, including any potential conditions.

Dr. Lopez-Talavera seems to be steering the team toward the next goals, including worldwide filings (FDA next?) and positioning blarcamesine as both a complementary and alternative therapy to current MAbs—potentially addressing 100% of Alzheimer's patients.

“This MAA submission is the first for oral blarcamesine as we are requesting a review of the Marketing Authorization Application with the aim to move closer to bringing this therapy to patients with Alzheimer’s disease worldwide,” said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development of Anavex. “Blarcamesine’s safety and efficacy profile could represent a novel treatment that could be complementary or an alternative to anti-beta amyloid monoclonal antibody drugs.”