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Isis Pharmaceuticals, Inc. Message Board

  • jimbotool jimbotool Jan 29, 2013 12:01 PM Flag

    Stan Crooke,CEO ......almost perfect nam'e'...speaks......

    October 19, 2012 conference call (transcript on Seeking Alpo) regarding the tumors found in mice (some at less that one human dose, most at only 2x the human dose per page 242 of FDA briefing docs) the "independent scientists who performed the studies" (whom they hired, of course) "concluded that... All findings were ...not considered relevant...with which we agreed" AND "We were obviously very encouraged by these data" A few seconds later " It is true that an FDA reviewer came to a different interpretation." ...OK... So they apparently chose to ignore the FDA official "Guidance for Industry " on "Interpretation of Chronic Rodent Carcinogenity Studies of Pharmaceuticals".( Stan, FYI it's right on their website). Watch the FDA approve this KYnamro BUT only for "ages 12 and older" ( per eligibility age for the pivotal final Phase 3 trial) FWIW min. age changed to 18 for all current trials on clinical trials.gov

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