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Zalicus AŞ Message Board

  • timothy732 timothy732 May 6, 2013 1:05 PM Flag

    Proof of concept for Z944

    A phase 1b (proof of concept) will be initiated where exploratory work is completed before a full phase 2 study. This is what is happening now because they have novel targets to hit (hence working closely with FDA to agree on measurement) and will involve humans both healthy and specific patient populations. This is what Corrigan is referring to when he mentions "further development".

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    • chevelle_69 May 6, 2013 2:52 PM Flag

      "Phase II: Placebo-controlled trials involving approximately 100 to 500 volunteer patients who have the disease being studied. The goal of this phase is to establish the "proof of concept" - i.e., the medicine effectively treats the disease. Researchers continue to evaluate the drug's safety and look for side effects, and determine optimal dose strength and schedule (e.g., once or twice daily). Phase II studies can take from six months from one year to complete."

      Straight from Merck's website

      You may be right Tim....I've convinced myself that the hold up is money related and/or they are seeking a partner or maybe they are still waiting on the FDA.