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Endorex Corporation (DOR) Message Board

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  • dogdayevening dogdayevening Sep 28, 2005 9:52 AM Flag

    How I see it (delisting)

    Fast Track can be 6 months. See below on ELN

    Market Pulse: Biogen, Elan file supplemental Tysabri application for MS
    Monday September 26, 4:23 pm ET
    By Carla Mozee

    SAN FRANCISCO (MarketWatch) -- Biogen Idec Inc. and Elan Corp. Plc said after Monday's closing bell that they have submitted a supplemental biologics license application to the Food and Drug Administration for Tysabri for the treatment of multiple sclerosis. The application includes a revised label and risk management plan and a safety assessment of patients treated with Tysabri in clinical trials, among other data. The companies have also requested priority review status for the application, which, if granted, would result in action by the FDA about six months from the submission date, rather than 10 months for a standard review.