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Investor2014

11/21/25 10:40 AM

#509265 RE: boi568 #509264

1. Is an issue, but not due to your explanation. Simply because there was no dose arm separation as most patient landed on about the same 30mg dose due to tolerability / titration issues. Hence pooled dose arms and not ITT TLD dose/response data.

2. You are again incorrectly on about a non-standard distribution.

3. Tau and microtubules sit at the heart of the neuronal injury in Alzheimer’s. Tau based biomarkers in CSF, blood and imaging are not tied to the monoclonal antibody class. They are part of the core biological definition, staging, and prognosis of the disease, and regulators already recognise CSF tau together with amyloid measures as qualified biomarkers for trial enrichment. For any putative disease modifying therapy that acts downstream of amyloid, or in parallel to it, movement in tau and related neurodegeneration markers will remain highly relevant as supportive evidence, even though at present regulators still insist on clinical benefit rather than tau alone as the primary basis for approval.
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Hosai

11/21/25 11:20 AM

#509270 RE: boi568 #509264

Technically Anavex beats the MABS on the N part of the A/T/N with the stat sig grey matter preservation (correlated with the cognitive benefits) and significantly less enlarged ventricles vs as we know disproportionate shrinkage with the MABS with as of yet unknown implications.
Blarca also had a larger effect size for nf-l vs placebo than Lecanumab (though Lecanumab closer to being stat sig on this - 0.28 p value vs 0.06) respectively. Donanemab on phase 2 reported - "No significant differences in plasma levels of amyloid-ß 42/40 and neurofilament light chain were observed between treatment arms at the end of treatment.".
For phase 3 - " No treatment difference was observed for plasma NfL at Week 76, but a larger increase was observed in the donanemab arm compared to placebo at Weeks 12 and 24."
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sab63090

11/21/25 12:15 PM

#509286 RE: boi568 #509264

boi568

I think you do a very good job of keeping people informed, especially on what was apparently shortcomings presented by Anavex now; sadly I had thought that the rapporteurs were keyed into these data points and suggested we move forward, at least as reported by quotes attributed to Missling....so we filed!

Oh boy, what will he say in a few days about this?
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Bourbon_on_my_cornflakes

11/24/25 12:14 PM

#509620 RE: boi568 #509264

Shouldn't a subgroup analysis adequately answer your points 1 and 2?
Per biomarkers, wouldn't the brain volume data answer #3?
Good post BTW