From today's PR: Given the size of this critically
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Posted On: 03/05/2021 10:23:45 PM
From today's PR: Given the size of this critically ill population relative to the trial’s size (62 out of 384 patients), the Company has concurrently filed an additional protocol with the FDA using the existing sites from its CD12 trial to quickly enroll patients in this population during the pendency of these ongoing regulatory discussions. The Company has continued to enroll patients (45) through the open-label arm of the CD12 trial, and is working with regulators here and abroad to expedite this process.
My response:
Sounds like they are saying that the 24% reduction in deaths vs SOC did include severe & critical, and the 24% would be higher if they had a higher percent of critical cv19 patients. Thus, a small %$ of severe folks on placebo, died. So they will continue the s/c trial, maybe only accepting critical folks, who should be quite willing to enroll. But they will continue discussions to pursue approval in the US, Canada and the UK.
My response:
Sounds like they are saying that the 24% reduction in deaths vs SOC did include severe & critical, and the 24% would be higher if they had a higher percent of critical cv19 patients. Thus, a small %$ of severe folks on placebo, died. So they will continue the s/c trial, maybe only accepting critical folks, who should be quite willing to enroll. But they will continue discussions to pursue approval in the US, Canada and the UK.
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