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Re: boi568 post# 445139

Tuesday, 01/02/2024 10:55:45 AM

Tuesday, January 02, 2024 10:55:45 AM

Post# of 462173
Yes, but make sure you understand "placebo effect". It affects both the drugged AND placebo arms. A high placebo effect does not excuse a trial's failure. For those who don't understand why, consider what the drugged arm's scores would be without a high placebo effect.

The company is going to try to argue not that the placebo effect was "high", but that the placebo effect in the placebo arm was "higher" due to a disease severity difference in the placebo population. Note that it is unspecified whether the difference is higher disease severity or lower. The argument is going to be tough to make, because who knows if placebo effect should be higher in a more severe, or a less severe, Rett population? What is the scientific basis or clinical support?

So we have a long row to hoe with these results.
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