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Regado Biosciences, Inc. Message Board

  • who_gnu_1235 who_gnu_1235 Jul 24, 2014 10:37 AM Flag

    DD FDA trial halt

    Contrary to other messages, there have been severe reactions. My take is that they are much closer to life threatening than to a rash. How many of these are in the RGDO arm vs the control arm are known only to the safety board. If the former then this could end up like AFFY, if the latter then we could see huge upside.
    I'm leery but will to listen to others more familiar with the company.

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    • They don't stop a trial for a rash. There is obviously something much more significant and shareholders have not been informed. This could take some time to figure out. From what we know there is 3 out of 600 that experienced severe allergic reactions. I am assuming the reactions were similar enough and the DMSB wants to know for sure what's the cause of these immune reactions.
      They will dig deep into these 3 subjects about their health histories and compare them.
      The timing of the trial halt leaves investors with some questions and concerns.
      If they say trial will resume without significant changes that would be very positive and should send this straight up. It will be interesting to see what the limitations or restrictions will be placed upon RGDO. Will they have to Re-Enroll? Change criteria? I'm not sure.
      So far, the Allergic Reactions are under 1% of tested population, so I am betting that the DMSB and FDA will decide to allow RGDO to run this trial...but there may be some all depends on what they discover is the cause.
      They need to know why is this safe in 99% of the population and not so safe in about .5%. Blood Type, Genotypes, a predisposed problem, this will take some time to figure out the why question.
      I see a lot of upside potential and that is why I took a position on Friday.

    • blah blah you know nothing!

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