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Column 1 Column 2 Column 3 Column 4 0 CDER Breakthrough Therapy Requests Received in Fiscal Year 2015 1 Cohort: October 1, 2014 - February 6, 2015 2 Total Requests Received Granted Denied Performance 3 39 5 9 97%* 4 * Percent of actions taken within 60 days of receipt of the request for breakthrough therapy designation.
FDA Grants Orphan Drug Designation, page-6
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