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DARA BioSciences, Inc Message Board

  • f0sizzl3 f0sizzl3 Feb 22, 2013 9:45 AM Flag

    y we r in DARA$

    On November 2012, DARA submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for KRN5500. Since CIPN has no current approved therapies, KRN5500 addresses a significant unmet medical need.

    Expecting an abbreviated new drug application (ANDA) for Gemcitabine to be filed with the FDA very soon. Per investor presentation, this ANDA was scheduled for Q4 2012 submission to FDA for wide ranging cancers.

    Given the promising results from its Phase 2a trial, DARA is currently seeking potential development partners, with the intention of initiating a Phase 2b trial for KRN5500 in 2013 once collaboration has been established.

    In September 2012, DARA entered into an exclusive agreement with the Helsinn Group of Switzerland for U.S. commercial rights to Gelclair(R), an FDA-cleared product for the treatment of oral mucositis. DARA plans to launch Gelclair in the first quarter of 2013.

    Waiting on potential partnership info & clinical trial update from the National Cancer Institute on another study with KRN5500 in expanded potential for use in other neuropathic syndromes.

    Sentiment: Strong Buy

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