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Investor2014

02/09/24 2:40 PM

#451517 RE: Steady_T #451510

Do you know why the absolute change in the treatment arm appear larger in the A2-73 vs. trofinetide?

I am discussing the absolute change in the treatment arm between 2-73 and Trofinetide.


Was there placebo effect in both the EXCELLENCE arms that was about equally large and if not why not?

You see this is exactly what Doc discussed and estimated in his post the effect size of A2-73 vs placebo, which is exactly relevant to the point you bring up.

It is also why I said what matters is the difference between the drug and placebo arms, certainly for approval.

Anavex have some theories and assumptions to explain the result, but nothing concrete (yet) to conclusively dispel that A2-73 doesn't appear to work much better than placebo, whereas trofinetide did although not with impressive clinical outcomes or with few or insignificant side effects.

At best the EXCELLENCE trial was inconclusive, with hopes that eg. the variability in subjective scoring and imbalance between the placebo and drug arms are to blame. Regardless, the most likely outcome now seems to be a new trial, which could perhaps with some hope be a confirmatory trial of a conditional approval.

The chance of approval is for me now much lower than the about 50% I am on record as having before the EXCELLENCE readout. What is yours now?