Anavex Life Sciences Corp (AVXL)

[12x]

My 4% is for any approval (Full or conditional) without an additional good sized P3. The 2b/3 was small, did not meet primary endpoints and was too short…

Thanks for sharing your perspective, Doc. I did a bit of digging into EMA’s history of conditional approvals in the CNS space and came across a few examples:

• Spinraza (SMA, 2017): Approved in Europe with relatively short-term efficacy data, while confirmatory work was still ongoing.
• Zolgensma (SMA, 2020): CMA granted off a single-arm ~20 patient study because of the huge unmet need, with confirmatory obligations attached.
• Exondys/Drisapersen (DMD): EMA conditionally approved exon-skipping drugs in Duchenne on thin datasets before requiring more robust trials.

From what I can tell, EMA’s philosophy in those cases was: allow access now, but require a confirmatory trial to secure long-term approval.

That made me wonder if Blarcamesine might fit a similar pathway. The recent $150M ATM coming just ahead of CHMP could be simple contingency funding — or maybe it’s partly to show EMA there’s a clear plan and resources for the confirmatory trial if CMA were on the table.

Curious what you think, Doc — do you see these CNS precedents as relevant here, or do you view AD as a fundamentally different case?