Yes and that Phase 3 trial took more than 4 years from FDA tick off to announcement of results and another 15 months to get FDA approval.
Neuren (NEU) - ASX Announcement 13 October 2017
Neuren confirms Phase 3 plan for Rett syndrome at FDA Meeting
Melbourne, Australia, 13 October 2017: Neuren Pharmaceuticals (ASX: NEU) today announced that at
its End of Phase 2 Meeting, the US Food and Drug Administration agreed with Neuren’s proposal for the
key elements of its clinical development program to support a New Drug Application for trofinetide to
treat children and adults with Rett syndrome.
Just to clarify further, the first subject enrolled in that Pivotal P2 trial in April 2016. So that's a year and a half from first enrollment in P2 to get to sit down with the FDA to plan elements of the P3, which took 4 years to get to results announced stage, and a further 15 months for approval.
Almost nothing in the world requires more patience that being a biotech investor.
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