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Lpath Inc. Message Board

  • jamess.reed jamess.reed Apr 1, 2013 7:54 AM Flag

    Asonep trial. The Longer it continues the better

    Further study details as provided by Lpath, Inc.:
    Primary Outcome Measures:
    •Progression-Free Survival [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The study will use a two-cohort design based on an 8-week PFS rate. Treatment will be considered promising if at least 12 out of the first 22 eligible subjects entered in the Cohort 1 of the study are progression free at Week 8. Enrollment of Cohort 2 will then proceed and be considered worthy of further evaluation if at least 25 out of 39 eligible subjects are progression free at Week 8. If no efficacy signal is observed after enrollment of 22 subjects in Cohort 1, the second cohort will not be enrolled and the clinical study may be stopped.

    So if in a few months they should be able to announce the # and % of progrression free subjects? No double blinding here.

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