Hi Mr Street
Not yet knowing the size and length of the PMS Phase 3 trial makes estimating timelines tricky, but my rough guess is that you need to allow at least 4 years.
I would allow at least 2 quarters for Phase 3 trial planning and preparation (it took almost 10 months between the plans for Phase 3 in Rett being announced and trial commencement).
I would allow 2.25 years for the trial, based on the length of the Phase 3 Rett trial for trofinetide, Acadia’s estimated timeline for its Phase 3 trial in PWS and Harmony Bioscience’s estimated timeline for its Phase 3 trial in PWS.
I’d allow a minimum of 2-3 quarters for post-trial analysis, evaluation, and refinement of trial data and results before NDA submission (Acadia took 7 months for this stage)
FDA priority review takes 8 months in total (2 months to submission acceptance + 6 months).
So my guesstimate is at least 4 years to approval. If things were to run smoothly – Q4 2028.
Please note, this is just my rough guesstimate.
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