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Posted On: 02/19/2021 7:50:41 AM
Post# of 154644
summary on CD12 timeline
Basically three milestones after LPLV (last patient last visit). LPLV for CD10 is 14 days after enrollment (FE) and CD12 is 28 days after FE
1. Database Lock-6weeks. This involves all verification that needs to happen for every patient and signed off by all sites. Once data is locked, nobody can change anything related to raw data.
2. Data unblinding-1week. This step could be faster if everything goes as planned but allow xtra.
3. Top line report-1week.
So 8 weeks after LPLV should be the typical time to expect top line report. this pretty much aligned with CD10 timeline. Enrollment completed 6/11; LPLV 6/25; top line report 8/11, basically 47 days or a little bit less than 7 weeks after LPLV.
Mapping it to CD12, 12/15 enrollment completed, LPLV 1/12. Estimated time for database lock 2/23 and top line report after 8 weeks is 3/9.
Even if FDA requested raw data they won’t get it until database lock which I expect to happen some time next week.
~hungrymax / stocktwits
Basically three milestones after LPLV (last patient last visit). LPLV for CD10 is 14 days after enrollment (FE) and CD12 is 28 days after FE
1. Database Lock-6weeks. This involves all verification that needs to happen for every patient and signed off by all sites. Once data is locked, nobody can change anything related to raw data.
2. Data unblinding-1week. This step could be faster if everything goes as planned but allow xtra.
3. Top line report-1week.
So 8 weeks after LPLV should be the typical time to expect top line report. this pretty much aligned with CD10 timeline. Enrollment completed 6/11; LPLV 6/25; top line report 8/11, basically 47 days or a little bit less than 7 weeks after LPLV.
Mapping it to CD12, 12/15 enrollment completed, LPLV 1/12. Estimated time for database lock 2/23 and top line report after 8 weeks is 3/9.
Even if FDA requested raw data they won’t get it until database lock which I expect to happen some time next week.
~hungrymax / stocktwits
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