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Affymax, Inc. (AFFY) Message Board

  • pissy_joe65 pissy_joe65 Jul 31, 2013 9:10 AM Flag

    Read...Excerpt from the Fresnius Medical Care CC..........

    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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    • I read that also, not sure how to react...is this good or bad?how would they determine if o could be given to a patient then?...a dna test prior ? seems expensive. It also looks like it wasn't human error, which is what I was hoping for, unless this is a cya move by Fresenious

 
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