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ImmunoGen, Inc. Message Board

  • networthdev networthdev Feb 20, 2013 11:23 AM Flag

    Breakthrough Designation & IMGN

    Would be a nice surprise, checkout PCYC and the PPS benefit. :-)

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    • Just think of the bounce, we would get. If short, and puckering today, may want to cover. These babies can really take off suddenly, check out SRPT today, gotta love biotech's. :-)

    • PCYC, gotta love it. IMGN could be next. :-)

      • 1 Reply to networthdev
      • 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"

 
IMGN
11.82+0.16(+1.37%)Aug 29 4:00 PMEDT

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