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Titan Pharmaceuticals Inc. Message Board

  • cashflow599 cashflow599 Mar 19, 2013 8:45 AM Flag

    TTBP: AdCom briefing notes. CLEARLY favorable slant to issues & questions.

    TTNP: AdCom says drug safety is established.

    And they will limit their scope to TTNPs delivery system, etc. VERY good news, imo.

    During this meeting, representatives from the Agency and the Applicant will present:

    ? Data from the clinical trials performed to assess the efficacy and safety of
    Probuphine in the treatment of opioid-dependent patients:
    o While the study design (randomized, placebo-controlled, parallel group
    study of 6-months duration) is not novel, some of the analytic approaches
    and concepts are.
    o Because the systemic safety of buprenorphine has been characterized, the
    safety presentation will emphasize information about adverse events
    associated with the surgical implantation and removal procedures.

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