To me, the is good news.
I think this is what will happen...
After three months, all participants move to trofinetide, provided there have been no serious safety/toxicity issues and provided there is some indication of efficacy.
They then stay on trofinetide for as long as they want to continue and as long as it is available - hopefully, right up until the drug is approved for sale.
This is Acadia - and the FDA - planning for success.
If the drug works, they don't want to take the kids off it at the end of the trial.
And if the drug works, they don't want kids stuck on placebo for six months.
This will massively help recruitment - parents will know their kids will get the drug - either straight away of after three months.
Ann: Plans for Phase 3 trial in Rett syndrome, page-9
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