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Keryx Biopharmaceuticals Inc. Message Board

  • big_jake_ii big_jake_ii Apr 4, 2013 4:36 PM Flag

    Japan news should be coming any day now

    ....at least before the US and European NDA filing by the end of April.

    If the CKD market news is good , up we go!

    Sentiment: Strong Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Big Jake, you are rushing the NDA a bit don't you think. If you listened to the last CC Ron mentioned filing the NDA by the "END" of Q2/13, April is the "Beginning" if you didn't know that. Just saying. Sounds like they may be working on both applications together and will announce them a day apart at the end of June or early July to really screw with the shorts.

    • I don't really understand the obsession of my fellow longs with the Japanese data. As I recall, their plan is (I believe Bentsur told us) to publish in a peer-reviewed scientific journal. That means they have to prepare first a compelling manuscript. In my experience this takes about 3 to 6 months. Then, it goes in the review process, which is another 6 to 9 months including all changes the reviewers may request. If it isn't publish online but only as hard copies that may take another 3 months. Honestly, I wouldn't be surprised if this publication will come out not earlier than the end of this year perhaps even later.

      So in my mind, the clear catalysts for KERX are submissions of NDA and MAA followed by excellent phase 2 data in CKD and hopefully some exciting partnership or acquirer news. Stay tuned, it's worthwhile to wait for these "milestones".

    • dquach4588@sbcglobal.net dquach4588 Apr 4, 2013 5:39 PM Flag

      Japan file NDA on Jan 2013. The process takes about 6 months to 1 year.

 
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