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Pluristem Therapeutics, Inc. Message Board

  • amlatz amlatz Aug 11, 2014 7:02 AM Flag

    can anyone explain the meaning of the change in United Therapeutics study?

    google NCT01795950

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    • mdplanet Aug 11, 2014 9:11 AM Flag

      It looks like they added patients that are receiving IV prostanoid.

      "Have been stabilized, without dose changes for at least 30 days prior to the Screening visit on at least two approved PAH medications (e.g., PDE-5 inhibitor, ERA, prostanoid [as inhalation or infusion]); ****or IV prostanoid monotherapy. Subjects on an IV prostanoid must have been receiving therapy for at least three months prior to the Screening visit."

      The last half of the first sentence and the second sentence are new. So, yes, they have made the criteria less stringent by adding a new class of patients. The thing that bothers me is that it's been 18 months and they need to dose only 9 patients. A snail's pace....

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