Agreed. A safe drug but perhaps they have the wrong surrogate endpoint or unrefined measurement technique. Voices of the patients and the advocates, caregivers and clinicians should weigh heavily where it is safe. I do think that Janet Woodcock is trying to make some directional changes along with Dr. Temple but they seem to have an uphill battle where personalities are concerned or maybe other factors.
Sarepta Rare Disease Advisory Panel Meeting today, page-10
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