Thursday, December 10, 2020 3:32:26 AM
We are eagerly awaiting completion of our double-blind study. We are hopeful that RLF-100™ can be applied as a broad treatment, though we initially focused on patients who were in critical condition without other options — there is still much to learn about the effects of the drug. The FDA has already granted NeuroRx permission to start a phase II/III trial for inhaled use in patients who have slightly less severe symptoms, and we feel it is appropriate to make this drug available to patients under the FDA’s Expanded Access (EA) program.[u]We have also asked the agency to turn the EA approval into an Emergency Use Authorization so that this potentially lifesaving drug can be given to people with a high likelihood of dying
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