It’s almost 5 years since Neuren received Fast Track designation for trofinetide in Rett. And the green light for commencement of Phase 2 in Rett was already provided by the FDA in late 2012. So it will have taken almost 6 years from that point for the company to get through to commencement of Phase 3.
Having “fast track” designation is nice, but the reality is that the FDA can’t go any faster than the sponsor company.
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