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tradersbend

11/14/25 1:51 PM

#508116 RE: Doc328 #508107

Good job, pin a red rose on your A$$
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MayoMobile

11/14/25 2:06 PM

#508127 RE: Doc328 #508107

I think this is a good data point, thanks.

With that said, there is more nuance for me than the p-value alone. I'm at work right now so I'll leave it at that for now - but I do thank you for this.
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Hoskuld

11/14/25 2:13 PM

#508132 RE: Doc328 #508107

Totally agree: AD WT is valid but the COL24A1 needs to be verified prospectively. Still, make it accessible to AD WT asap while doing the testing.
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BakedLangostino

11/14/25 4:30 PM

#508193 RE: Doc328 #508107

Doc, I agree that another trial, a proper P3, is most likely needed. I sense a lot of disappointment right now is that investors thought the game was over, and just learned that it's only halftime (and there is an extra cost to watch the second half).

That said, I also believe (and I am far from a hopeless optimist if you've read any of my previous posts) that many advocacy groups and KOLs will be pressing the EMA for answers. Caretakers who need a pill-based solution; patients themselves; perhaps even doctors who are already overworked with too many caseloads.

Your analysis on the science is sound, and in a vacuum should be 100% accurate: another trial is needed.

But trials take time and it's possible that advocacy groups + compelling OLE analysis tilt the scales in Anavex's favor. Unlikely, but probably greater than 4%.

I think this is what @MayoMobile was getting at when he said he there may be more nuance, though I do not wish to speak for him. I wouldn't underestimate the power of political pressure. Just as I can see Dr. M deciding the best path forward is with the anti-amyloid FDA director and the new FDA head who doesn't seem to believe in long, additional and expensive trials for unmet needs.

It's not over. Halftime, extra innings, sure. But definitely not over. Thanks as always for your input.