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Steady_T

03/12/24 1:02 PM

#453917 RE: frrol #453916

What part of "potentially" is difficult for you?

Trials are sometimes stopped because the results are so good that it is considered unethical to continue and the NDA is filed.
It appears the the adult Rett trial results were good but not good enough to be pivotal. Or, more likely, the FDA wanted to see the pediatric trial and do one NDA for all age groups.
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ohsaycanyousee82

03/12/24 1:04 PM

#453918 RE: frrol #453916

So trial size was not a Missling mistake in your judgement?