(Total Views: 396)
Posted On: 09/18/2020 11:32:57 AM
Post# of 155737
Review at 195 patients is an efficacy, not a safety analysis.
Is this trial safe to continue (safety, completed already)
vs
Have we demonstrated unequivocally that this therapeutic even at one-half of full trial size (lower statistical power).
Safety review complete:
CytoDyn Receives Positive DSMC Recommendation for Leronlimab Phase 3 COVID-19 Trial with No Safety Concerns
Download as PDFAugust 04, 2020 4:12pm EDT
VANCOUVER, Washington, Aug. 04, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company, announced today an independent Data Safety Monitoring Committee (“DSMC”) completed its first safety review of the ongoing Phase 3 clinical trial (CD12) in patients with severe and critical COVID-19 and reported it saw no cause to modify the study. The DSMC reviewed compiled safety data from 149 subjects enrolled in the CD12 trial. The DSMC did not raise any concerns regarding safety and recommended that the trial continuhttps://www.cytodyn.com/investors/news-events/press-releases/detail/456/cytodyn-receives-positive-dsmc-recommendation-for
Is this trial safe to continue (safety, completed already)
vs
Have we demonstrated unequivocally that this therapeutic even at one-half of full trial size (lower statistical power).
Safety review complete:
CytoDyn Receives Positive DSMC Recommendation for Leronlimab Phase 3 COVID-19 Trial with No Safety Concerns
Download as PDFAugust 04, 2020 4:12pm EDT
VANCOUVER, Washington, Aug. 04, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company, announced today an independent Data Safety Monitoring Committee (“DSMC”) completed its first safety review of the ongoing Phase 3 clinical trial (CD12) in patients with severe and critical COVID-19 and reported it saw no cause to modify the study. The DSMC reviewed compiled safety data from 149 subjects enrolled in the CD12 trial. The DSMC did not raise any concerns regarding safety and recommended that the trial continuhttps://www.cytodyn.com/investors/news-events/press-releases/detail/456/cytodyn-receives-positive-dsmc-recommendation-for
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