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Astex Pharmaceuticals, Inc. Message Board

  • weightbayou weightbayou Feb 18, 2013 11:12 AM Flag

    I hope AZD3293 gets "breakthrough designation"

    "One of the most tantalizing new programs now being rolled out at the FDA is its brand new category for "breakthrough" drugs, offering a select number of companies a chance at a shortcut to the market based on early-stage data for transformational new therapies. So when Janet Woodcock, the influential director of the FDA's Center for Drug Evaluation and Research, started outlining how the program will work--indicating that a company can move from an expanded Phase I directly to commercialization, Bloomberg reporters were paying close attention.

    According to the business news wire, Woodcock says that companies which earn breakthrough status will have the ear of the agency. "We expect many of these would come available very quickly with Phase I data," she said."

    Sentiment: Strong Buy

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