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Monday, 06/19/2017 4:48:01 PM

Monday, June 19, 2017 4:48:01 PM

Post# of 8305
What is a Breakthrough Therapies: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm

"demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints".

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