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Galena Biopharma, Inc. Message Board

  • kozmokuz kozmokuz Feb 14, 2013 4:49 PM Flag

    Approval rate for phase 3 drugs

    The following stats are from the article "Success rates for experimental drugs falls: study" "Some 63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III, which requires a commitment to larger and much more expensive clinical trials. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.

    Not surprisingly, the numbers increase after that as the drugs had already shown success in the clinic.

    Approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval, although only about half were approved on their initial FDA review.

    The 80 percent approval rate, while seemingly high, is down from 93 percent seen in studies of earlier years".
    Combine these facts with the outstanding results from phase II and Neuvax is looking great for approval!!! Less

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