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Venaxis, Inc. Message Board

  • whogo70 whogo70 Jul 27, 2013 12:20 AM Flag

    How APPY plans to complete the trial by the end of 2013

    There's been some confusion on this topic, but if you read the transcript its pretty clear. The current enrollment is 200 per month, but this is increasing. If they started getting 300 per month then they could complete the enrollment in November.

    830 as of July/16
    1130 as of August/16
    1430 as of Sept/16
    1730 as of Oct/16
    2030 as of Nov/16th

    Here is the transcript:

    "At this point, we have approximately 830 patients who have either completed or currently enrolled in this study, awaiting the required 2-week follow-up, following the release from the hospital with initial diagnosis of negative for appendicitis. We're very pleased to say that the rate of patient enrollment continues to accelerate. The study is now enrolling patients from all of our participating hospital sites, and patient recruitment continues to improve on a month-by-month basis as we continuously work with the sites to further enhance the enrollment process.

    Based on our experience enrolling the previous 500-patient study of APPY1, which was conducted in 2011, we had estimated the completion of the clinical study and submission to the FDA by the end of the year. Now having the benefit of increased visibility into actual enrollment rates and behaviors of our hospital sites, we believe we are still on track to complete enrollment and announce top line data by the end of this year, with FDA submission to follow as soon as possible thereafter in Q1 2014."

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