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Affymax, Inc. (AFFY) Message Board

  • maxdad01 maxdad01 Jul 31, 2013 10:15 AM Flag

    OMONTYS OFFICIALLY MOVES FROM POST MORTEM INVESTIGATION TO FIELD TESTS W/ FRESENIUS

    AND FDA!!!

    FROM FRESENIUS' CONFERENCE CALL YESTERDAY...PUBLISHED ON SEEKING ALPHA, THIS PASSAGE ON PAGE 7 Q&A OF CHAIRMAN:

    Michael, on OMONTYS, your timing's impeccable. What I can tell you is that Takeda has been working with FDA and they are just almost at the point of getting agreement with FDA on a study that will be done in our clinics. It is a DNA type of study where they're going to be trying to understand what could potentially be within the individual that had the reactions, is there something we can learn and understand there? So it's a fairly scientific approach to what we're trying to do. But they continue to work and be very active in understanding what went wrong. So that is an update for you. And as I say, we'll be participating in that study. And I don't know how long it will take, I'll have to talk to the medical guys and see what they think it will take in terms of timing and evaluation of the data, things of that nature. But you should know that they have not stopped, they are continuing to work in trying to understand how they can make this better understood, if you will.

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AFFY
0.145+0.0099(+7.33%)Jan 28 3:59 PMEST

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