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Exelixis, Inc. Message Board

  • wilderguide wilderguide Nov 16, 2013 8:45 PM Flag

    EMA PRAC minutes 11/7/13

    I believe we are getting close to an EMA consideration. Cabozantinib was listed for consideration and "evaluation of an RMP in the context of an initial marketing authorization application procedure" when the PRAC met on 11/7/13. The PRAC ( Pharmacovigilance Risk Assesment Committee) is somewhat to the EMA as ODAC Ito the FDA. No results nor commentary are displayed, but this necessary step has been completed.
    For confirmation, see EMA PRAC minutes 14.1.2 page 55 dated 11/7/13. I like this a lot...
    We are about to get some news from across the Atlantic,

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      FWIW-Cabo is also listed on the agenda for the recent COMP (orphan drugs committee) meeting that took place 11/5-6. This can verified by seeking out page 4 of those minutes (the segment wrt ongoing evaluation). The current CHMP meeting began today, and will post highlights shortly after adjournment on 11/21. It is entirely possible we could see news out of Europe as early as Friday.

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