"FDA will make both Pfizer and Sarepta jump through some very expensive and time consuming hoops to prove GT safety and efficacy"
Huh just another @Uboy throw away line ? ... given FDA have awarded Pfizer FTD 6 months ago ?
Pfizer Receives FDA Fast Track Designation for Duchenne Muscular Dystrophy Investigational Gene Therapy | pfpfizeruscom
Anything that has to go back though the FDA takes a lot of time, and people whinge about the 30 days for ANP's minutes ......
FDA might have over 10.000 employees but that's nothing against the number of clinical trials underway - these things always take time.
Pfizer hits brakes on DMD gene therapy, page-4
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