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Whilst waiting for new news I thought I would revisit timelines for trofinetide to see what the "going it alone" strategy could mean and here are my assumptions on timelines as a conservative estimate. I have, conservatively, an FDA announcement occurring in September 2027 so 3 years from now.

What will be interesting is the period between top line results and the FDA announcement whether this would be the time a take over would occur as waiting until FDA approval to then be taken over will considerably delay the launch of the drug to the market (as we saw how well Acadia prepared for this well before the FDA announcement).

PMS Phase III Trial in NNZ-2591

Trial Commencement: 1st March 2025
Recruitment commences with 1st dose: July 2025 (5 mths)
Trial enrolment complete: December 2025 (5 mths)
Top line results announced: May 2026 (5 mths)
NDA submitted to FDA: January 2027 (8 mths)
NDA accepted by FDA: March 2027 (2 mths)
FDA approval (hopefully): September 2027 (6 mths)


Neuren Trofinetide announcements:
31/10/2019- Neuren announce that Acadia has commenced Phase 3 trial
17/03/2020- Neuren announce first patient dosed and that results are expected in 2021 & marketing approval in 2022
05/08/2021- Neuren announce completed enrolment of Lavender trial with top line results in Q4 2021
07/12/2021- Neuren announce positive top line data for trofinetide and plan NDA meeting with FDA Q1 2022 and NDA application mid 2022
19/07/2022- Neuren announce Acadia submitted NDA to FDA for trofinetide
13/09/2022- Neuren announce NDA accepted for priority review of trofinetide
13/03/2023- Neuren announce FDA approval for Daybue
18/04/2023- Neuren announce Daybue launched in US