Yes - good reminder 70FAB. Its hard to underestimate the significance of the following comment:
"Importantly, not only is the first phase 3 study that has meet primary endpoints in Rett syndrome, but it is also one of the first times a successful phase 3 trial has been completed in any neurodevelopmental disorder."
And we think there is still a chance the FDA would not approve?
This also means, I would assume, that once Trof is approved Neuren will be in the highly enviable position of having the first drug approved for any neurodevelopmental disorder. How will that be eh?
Ann: Rett Syndrome NDA accepted for Priority Review by FDA, page-99
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