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Sunshine Heart Inc. Message Board

  • networthdev networthdev Feb 22, 2013 6:53 AM Flag

    SSH & FDA "Breakthrough Designation"

    Check out the price action in PCYC, since recently receiving this status.

    Given the TREMENDOUS quality of life benefit, in addition to the even more SIGNIFICANT cost of care savings, for these patients and our medical system. SSH should seek FDA out on this, and become the FIST medical device to receive this designation.

    For those not familiar,

    "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.

    So far, we know that Vertex ($VRTX) has won breakthrough status for two drugs for cystic fibrosis, the approved drug Kalydeco and the experimental VX-809, now being studied as a combination therapy. According to Woodcock, a third drug has been anointed with the special status. And developers have submitted 18 for review, most of which are for cancer"

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