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Replies to post #514598 on Anavex Life Sciences Corp (AVXL)
02/11/26 3:46 PM
02/11/26 3:54 PM
Jesse Silveira
Analyst
0:24:21
Okay, thank you. If I have it correct, you have committed to running a confirmatory phase for a trial if approved for CMA using paying patients as a real-world cohort. Isn't that correct?
Christopher Missling
President and CEO
0:24:36
Sorry, what patients?
Jesse Silveira
Analyst
0:24:38
like paying patients in the E.U. Assuming you are actually approved under CMA, will you be running a phase IV trial with these patients?
Christopher Missling
President and CEO
0:24:46
We will run.
Jesse Silveira
Analyst
0:24:47
Or how would that look, I guess?
Christopher Missling
President and CEO
0:24:48
Yeah, we would run a trial as the regulatory body, the CHMP guidelines, provides for that you get approved, and then in parallel, you will run a confirmatory study. Yes.
So it's a very intriguing project to be part of, and the ACCESS-AD program consists of multiple features. Among them is also a review of healthy diet, also a supplement diet is part of that, and they're all separate, they're not together, and as I just mentioned, one part is explicitly a trial of blarcamesine in a placebo-controlled clinical trial.
Jesse Silveira
Analyst
0:28:01
Sorry if you mentioned, is this in early Alzheimer's patients or is there like a preventative component to this trial?
Christopher Missling
President and CEO
0:28:10
Yeah, so it's a good question. It could end up being a preventative also, but right now it's consistent with an early Alzheimer's population as a target population.
Jesse Silveira
Analyst
0:28:21
Okay, and this would be considered AD006 on your pipeline chart, is that correct?
Christopher Missling
President and CEO
0:28:27
That's correct, yes. That would be AD006.
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