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boi568

10/17/25 6:37 PM

#503501 RE: notbrad #503494

I don't think Jesse is suggesting a second Phase 3 trial as the condition.
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attilathehunt

10/19/25 10:00 AM

#503651 RE: notbrad #503494

Wouldn't a CMA pose a recruitment problem if a confirmatory trial is required? Why would anyone risk a 1 in 3 chance of being in the placebo arm



I don't think a confirmatory trial would have a placebo arm.
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Investor2014

10/19/25 10:26 AM

#503653 RE: notbrad #503494

A confirmatory RCT trial may be required as so far Anavex haven't run any as would be the norm. The outcome of the P2b/3 ended up looking more like a P2 trial than a P3 pass to protocol on all endpoints met with flying colours.

If a P3 RCT Confirmatory trial is a condition under CMA, then there are plenty countries to run the trial in where blarcamesine is not approved or marketed.