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La Flaca

11/13/25 1:23 PM

#507542 RE: Doc328 #507533

point taken - about 75%?

AVXL submitted information that IMO mitigates potential bias: MRI, biomarkers, and OLE data that is independent of dropout rates. imaging and biomarker data and OLE data. All of this information independenly confirms efficacy. Risk/benefit analysis doesn't seem that tough direct CHMP to make the right decision for patients, Doc. Perfection can't be the enemy of the good here. We're talking about people's lives!
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Hosai

11/13/25 1:41 PM

#507545 RE: Doc328 #507533

Doc I'm talking about people who actually took one of the drugs or placebo, i.e the starting figure (n) vs completion. In this analsys Blarcamesine had 64% dosed completed vs 74% placebo. Donnanemab 75% dosed completed vs 80% placebo.

If we go with initial randomization figures then yes would be lower for both as both Blarca and Donnanemab lost about 8% of patients between intitial randomization and starting the trial. Hence my point stands that blarca wasn't that far off in completion rates from Donnamab in terms of dosed vs placebo.

On top of this, as 50mg had most of the dropouts it meant 30mg had a 70% completion rate (versus 75% placebo as stated). This means the 30mg group completion rate was the same distance apart from placebo as donnanameb was dosed to placebo (75 to 80) - both had dosed completion 5 lower than placebo.
As we know 30mg blara, beats Donnamemab vs placebo on adas cog / cdr sb / brain bleeds / brain shrinking and only 48 weeks to show the efficary rather than 18 months.
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boi568

11/13/25 2:27 PM

#507563 RE: Doc328 #507533

What drop out adjustment do you apply for the pandemic conditions that occurred during the trial?
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frrol

11/13/25 3:19 PM

#507585 RE: Doc328 #507533

A couple of things:
1. Yes, drugged dropouts are high.
2. The trial was done under pandemic conditions, which is a mitigating factor. Though not completely: there were clearly tolerability issues. On the other hand: there is some evidence that tolerability itself was mitigated in the OLE.
3. Regardless of all the above, the ITT results should include the dropouts. (Unless Missling did some "modifications" but I doubt Jin would allow that.)