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Posted On: 01/27/2021 7:08:44 PM
Post# of 653
ZYESAMI (RLF-100), the NeuroRx COVID-19 Drug - was awarded Fast Track designation by the FDA in June 2020 and admitted to the Coronavirus Treatment Acceleration Program. NeuroRx is currently conducting Phase 2b/3 clinical trials, with read out data expected by January 28, 2021. Additional trials are being conducted via the NIH-sponsored ACTIV3 program and the I-SPY program.
Should the clinical trial currently underway demonstrate clinical and statistical significance, NeuroRx hopes to receive EUA for ZYESAMI (RLF-100) in the first quarter of 2021, which EUA will provide NeuroRx with a year in which to complete the Chemical Manufacturing Controls (“CMC”), plant inspections, and advisory board requirements associated with traditional drug approvals.
Should the clinical trial currently underway demonstrate clinical and statistical significance, NeuroRx hopes to receive EUA for ZYESAMI (RLF-100) in the first quarter of 2021, which EUA will provide NeuroRx with a year in which to complete the Chemical Manufacturing Controls (“CMC”), plant inspections, and advisory board requirements associated with traditional drug approvals.
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