Monday, September 21, 2020 5:56:09 PM
"Veklury is currently available in the U.S. under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19. The filing is the final tier of the rolling NDA submission that was initiated on April 8, 2020."
Approval came on 5/1/20. (Link below)
"Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19"
22 days for EUA. 22 days from NeuroRX's submission for Aviptadil on 9/17/20 is 10/9/20. Since the early days of Covid back in April, the FDA has worked out a lot of kinks and streamlined somewhat, so I hope we hear something sooner, but trial results and EUA is looking good for early to mid-October.
https://www.gilead.com/news-and-press/press-room/press-releases/2020/8/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-veklury-remdesivir-for-the-treatment-of-covid19
https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gileads-investigational-antiviral-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid19
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