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Amarin Corporation plc Message Board

  • rml360 rml360 Jan 23, 2013 10:45 AM Flag

    fda response about Amarin getting notified direct or not

    Dear Rick,

    Thank you for writing to the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER).

    The only means of notification is by publication in the Orange Book, no letters are sent. We don't notify a sponsor if a decision is pending.

    Kind regards,

    SV
    Division of Drug Information
    Center for Drug Evaluation and Research
    Food and Drug Administration

    For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter @FDA_Drug_Info.

    This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

    See you all next o/b update

    Sentiment: Strong Buy

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    • Good work in clearing that up! Thank you!

      Sentiment: Strong Buy

    • the only thing that contradicts this is that Joe was saying they have weekly meetings with the FDA so the part about the notifying that the decision is pending might be BS? The comments from MKM back in november contradict this as well as Joe was saying they might be notified of a decision before o/b update, not sure who to believe. This might be a "special cirumstance" not sure

      Sentiment: Strong Buy

      • 1 Reply to rml360
      • You answered your own question already in the FDA disclaimer. Basically the answer does not apply to all situations and is not necessarily the position of the FDA. LOL

        "This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed."

        Sentiment: Strong Buy

 
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