The FDA is the one that set the points on what should be the improvements studied. They are the ones in control of the study perimeter, so they know the improvements.
The results vs the placebo was outstanding, and the trend lines were also "typical" as time went on ie placebo effect went down and the drugs effects kept on showing improvement over a long period of time, which is why the FDA wanted a longer 12 week trial.
The drug works and will get FDA approval.
At worst they may request ACADIA show a plan on how they will manage the diarrhea.
We are now sitting on a gold mine. $8 take over offer is absolutely criminal now.
Ann: Positive topline results from Phase 3 trial in Rett syndrome, page-38
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