NEU neuren pharmaceuticals limited

Ann: Rett Syndrome NDA accepted for Priority Review by FDA, page-56

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    Howie, read Hottod's post clarifying links. This is where I got the charts from too. And Neu only provide a direct link to the Acadia presser on the 10.01.23.

    As Hottod has mentioned, the wording is more so a caveat that until FDA approval, Trofinetide can't be assumed to be safe and /or effective (even if the P3 results indicated otherwise). I agree it is somewhat sloppy that Acadia have two different charts dated the same day though. Let's just hope their NDA filing didn't have such discrepancies!.
 
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