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Re: dloggold post# 35434

Friday, 02/04/2022 12:16:24 PM

Friday, February 04, 2022 12:16:24 PM

Post# of 42746

they have to wait 60 days from january which is march, then put together the data to amend the EUA application.
were talking the fall at earliest


We don't know when the trial completely enrolled. The Clinical Trials website stopped updating on November 29th. Humanigen announced full enrollment on January 5th. It could be either of those dates. And it took 2 months from LIVE-AIR data unblinding in March for the original full EUA application to be submitted in May. This time they are only doing an amendment to the application. It should take less than 2 months from unblinding. Remdesivir received their EUA 7 days after data was unblinded to the DSMB in an interim review. There is no set timetable on how long things take with the FDA. An EUA in fall seems very pessimistic though not impossible. But I'm not worried about the EUA right now. I just want to see data. I want to see that we hit stat sig again. If that happens, HGEN's share price with skyrocket because an EUA will be inevitable.