$HGEN Gesendet: Mittwoch, 30. März 2022 um 16:31 Uhr Von: "Tim Morris" <tmorris@humanigen.com> An: Elisa Betreff: Re: Database lock Database lock occurs once all the data has been entered and verified. ....The protocol follows patients for 60 days. The primary endpoint is measured through day 29. It is important to gather all the data through day 60 to lock the database. We spend a tremendous amount of effort tracking down missing data the most important of which is the patient still alive. As these patients have been discharged it is a challenge to confirm if the patients are alive or not. For ACTIV-5 NIH is in control of the database. We haven’t given any guidance on database lock but the Day 60 data is needed to lock the database. ..... I recognize the anxiety around the top line release but safe to say we are working with the NIH to make sure all the data is collected and entered. Top line data will be released when it is available.
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