I've been looking at the FDA website having googled Fast track vs Breakthrough. Not sure if I'm missing something but it reads to me more like fast track is designed for drugs going after an unmet need whereas breakthrough therapy is more for when an applicant thinks their drug will be superior to existing therapies. In the context of Neuren both PMS and PH would be more in the Fast track situation whilst Angelman's is more for breakthrough. This is just my take on reading the website so happy to hear from anyone who has a different take, thanks
Ann: Fast Track granted by FDA for NNZ-2591 in Pitt Hopkins, page-26
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