PPMD is proud to help author and share the attached letter to Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA. Along with CDMD at UCLA, the Duchenne Alliance, and The Race to Yes, PPMD is asking Dr. Woodcock to consider moving Sarepta’s Advisory Committee date to the same week in November as BioMarin’s. We have also asked the agency why the Ad Comms are separated by month and what this separation of time could mean for review. As a community we are doing everything we can to better understand last week’s decision by the FDA and we will update you with any news we receive.
Read the submitted letter: