I was a bit disappointed when John Pilcher explained Acadia were not intending to lodge the FDA application for Trofinetide until "mid 2022", so with even the accelerated assessment afforded Trofinetide as an orphan drug in the US, it is not likely to be released for use until at least 12 months from now.
Does anyone here know why it should take so long for the application after completing the Ph3 trials and proving manufacture? Or are Acadia stalling so that we cannot run with approval into other markets any earlier?
BTW ... very happy after a loooong period of hair pulling.
Where to in 2021?
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