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Raptor Pharmaceutical (RPTP) says the FDA will require additional time to complete its review of...

Raptor Pharmaceutical (RPTP) says the FDA will require additional time to complete its review of the New Drug Application for RP103, Procysbi, for the potential treatment of nephropathic cystinosis. The company received notice today that the PDUFA goal date has been extended from January 30, 2013 to April 30, 2013in order to provide more time to complete the review of information submitted. The agency hasn't asked for any additional studies.
Comments (2)
  • pedromm
    , contributor
    Comments (17) | Send Message
     
    3 Months more...well the most important is that RPTP has good chances of approaval. No more studies required...nice

     

    Will be interesting to see aproaval in EUA and in Europe almost at same time...

     

    Regards
    21 Dec 2012, 05:51 PM Reply Like
  • rsab02
    , contributor
    Comments (2) | Send Message
     
    does anybody know how to find out who's shorting the stock?
    23 Dec 2012, 05:10 AM Reply Like
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