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Arena Pharmaceuticals, Inc. Message Board

  • tiger_josef tiger_josef Jan 11, 2013 10:29 PM Flag

    100% sure NAILED IT

    Search for “9 November 2012 EMA/501015/2011 Rev.1 Product Data Management”

    ===============
    Per ARNA's Q3 2012 Call Craig Audet indicated that he was happy to say that ARNA submitted the response to the CHMP 120-day assessment report in OCTOBER

    Now look on Page 5 (when you find the link) which is Phase 2 Responses to List of Questions – LoQ (60-day Assessment) which is AFTER the end of the 120- day. THE ONLY SUBMISSION DATE IN OCTOBER is October 12, 2012 and here is the Breakdown of those 60 days to day 180

    Timetable 2: Responses to List of Questions – LoQ (60-day Assessment after clock-stop for responses) – 2nd phase

    Submission Date (*) = 12-Oct-2012
    Restart = 14-Oct-12
    CHMP (Co-) Rapporteur Assessment Report = 12-Nov-2012
    PRAC Rappourteur’s RMP Assessment Report = 12-Nov-2012
    Comments on RMP AR from CHMP and PRAC members (**) = 16-Nov-2012
    Updated PRAC Rapporteur RMP AR = 19-Nov-2012
    PRAC Teleconference (X) = 27-Nov-2012
    PRAC Output Adoption (XX) = 29-Nov-2012
    Comments on CHMP (Co) Rapporteur Report (**) = 3-Dec-2012
    Opinion or adoption of List of Outstanding Issues (LoOI) = 13-Dec-2012

    Footnotes:
    (*) The Agency strongly recommends submitting the application before the submission deadline in case the submitted dossier needs to be re-dispatched.
    (**) Comments from CHMP and PRAC members are not made available to Applicants.
    (X) PRAC/CHMP Teleconference: CHMP members are routinely invited to join via TC PRAC plenary discussions for their products.
    (XX) PRAC RMP Assessment Overview and Advice
    ====================

    Therefore, absolutely with no doubt the 180 Day ends on December 13, 2012 and Jack said that he did not receive the 180 day List of Outstanding Issues from CHMP in the January 9th Conference.

    From the above also notice how PRAC was INVOLVED in the whole process during the 60 day Phase 2 period.

    Based on the above, I strongly believe that we are golden for January 18, 2013

    Sentiment: Strong Buy

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