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Wednesday, March 30, 2022 12:12:24 PM
https://stocktwits.com/Elisa2Summer/message/448394341
I was irritated by this discussion about the 60 days + asked ir about it. here is the answer.
1- Our public guidance is top line data would be out late Q1/early Q2.
Database lock occurs once all the data has been entered + verified. Database has multiple data points for each patient. 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.
2 - For LIVE-AIR we were able to freeze the database at Day 29 to come up with the top line data. 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 can confirm enrollment is complete and the team is working to gather all the endpoints.
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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