There have been a total of 10 drugs (CDER) given breakthrough designation this year from the FDA
http://www.fda.gov/downloads/Regula...antAmendmentstotheFDCAct/FDASIA/UCM380724.pdf
Also you can see the below (CDER) requests for 2014 below. I wonder if PRR was in the 51 denied? Prima has never stated whether it has applied for breakthrough or if it has been denied????
Column 1 Column 2 Column 3 Column 4 0 Total Requests Received Granted Denied Performance 1 97 31 51 99%*
Ann: Notice of Grant received from Canadian Patent Office, page-6
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