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Cytokinetics, Incorporated Message Board

  • dctrig dctrig Mar 14, 2013 3:16 PM Flag

    FDA Just Gifted Cytokinetics

    Just plug in "ALS" for "Alzheimer's" in below news piece:
    Just weeks after pointing R&D groups engaged in Alzheimer's drug research to early-stage patients, the FDA is proposing to lower the bar biotechs will have to clear in order to gain an approval. And faced with a string of blockbuster collapses in Phase III, regulators are signaling a greater willingness to offer early, accelerated approvals for the most promising therapies that come out of the pipeline.
    cognitive improvements alone or preventive measures proven with biomarkers.

    These new standards--initially addressed in a new draft guidance last month--could radically alter the R&D landscape for Alzheimer's drugs, widely perceived as a golden ticket to instant blockbuster status. They could also open a pathway to new therapies that could help millions of patients grapple with a mysterious and terrible disease.

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