InvestorsHub Logo
Followers 3
Posts 173
Boards Moderated 0
Alias Born 08/18/2020

Re: None

Monday, 09/21/2020 5:56:09 PM

Monday, September 21, 2020 5:56:09 PM

Post# of 44690
Per this PR on 8/10/20, Gilead filed an NDA for Remdes*vir (Veklury) on 4/8/20. (Link below)

"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