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There have been a total of 10 drugs (CDER) given breakthrough...

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    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%*
 
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