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Posted On: 03/05/2021 8:49:42 PM
Post# of 151008
This tells you all you need to know. An additional protocol files with the FDA. No EUA. Period...
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.
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.
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