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Array BioPharma Inc. Message Board

  • cl124cl cl124cl Aug 1, 2014 2:42 PM Flag

    ARRY response


    Below is a link to the FDA website showing the orphan drug designation status as “designated” for Binimetinib in ovarian cancer. The FDA also provided orphan drug designation status for Binimetinib in melanoma last year.

    I hope this helps clarify things.


    yoohoo won't let me post the url, so I removed it

    C L

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    • Second response:

      Although we are very pleased with the designation, it is not material news. I think it’s more common for companies to issue a press release if they get “breakthrough” status on a product.

      My question was:
      Is there a reason that Array does not do a press release on this subject??


      • 1 Reply to cl124cl
      • “breakthrough” status " ..What is a Breakthrough Therapy?
        A new drug may be designated as a breakthrough therapy by the Food and Drug Administration (FDA) if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence suggests it provides a substantial improvement over existing therapies. Once the breakthrough therapy designation is requested by the drug sponsor, the FDA and sponsor work together to determine the most efficient path forward..

        Sentiment: Hold

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