“but it is also one of the first times a successful phase 3 trial has been completed in any neurodevelopmental disorder."
So imagine the damage the FDA would do to research into rare diseases and neurodevelopmental disease if a study that met all primary and secondary endpoint with statistical significance and totally safe, was rejected???
It would set the industry back decades. Investment would be hammered.
…and the people who need these discoveries the most will continue to suffer.
I suppose we’ll know soon enough.
Ann: Rett Syndrome NDA accepted for Priority Review by FDA, page-102
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