“...Enrollment in the 270-patient global Phase 2/3 study with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) is more than 50% complete. The study is approved in six countries and is on track to deliver top-line data in the first quarter of 2021. This study is focused on and powered for efficacy evaluation, and recently received a unanimous recommendation to continue by an independent Data and Safety Monitoring Board (DSMB), following a pre-scheduled safety review of the first 70 patients to have been treated for 14 days. A prescheduled, unblinded futility interim analysis will also be conducted by the DSMB in the coming weeks, evaluating data from the first 135 subjects that have reached the primary endpoint...”
The RDHL PRESS RELEASE HAD THIS LANGUAGE FOLLOWING THE PARAGRAPH ABOVE FROM SEC 6k:
“...The parallel U.S. Phase 2 study with opaganib (NCT04414618) has completed enrollment of all 40 subjects, with topline data expected in the coming weeks. This study is not powered for efficacy and is focused on safety evaluation and identification of efficacy signals...”
So, RDHL MAY HAVE AMMO FOR A BLOCKBUSTER PR THE WEEK OF DECEMBER 7th.
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