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Posted On: 02/17/2021 11:04:22 PM
Post# of 148870
Look here
Great summary on CD-12 timeline expectations by "Hulk" on the Yahoo board:
"Just want to share some industry knowledge regarding timelines after speaking with a trial statistician who leads trial design in multiple pharmaceutical companies.
Basically three milestones after LPLV (last patient last visit). LPLV for CD10 is 14 days after enrollment and CD12 is 28 days after full enrollment.
1. Database Lock - 6 weeks. This involves all the 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 - 1 week. This step could be faster if everything goes as planned but typically targeted for a week allow some wiggle room.
3. Top line report - 1 week.
BTW interim analysis typically goes faster as it’s more of identifying a trend and not all data are needed.
So 8 weeks after LPLV should be the typical time to expect top line report. I found 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. As much as I dislike Amrex they were ahead of industry standards for CD10.
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. If Amrex performs at same speed as in CD10, we would be looking at the topline report on 3/1.
There are a lot of guess why no news yet, well, my theory is nobody has verified data to do any analysis just yet. Even if FDA requested raw data from Amrex directly, they won’t get it until database lock which I expect to happen some time next week.
Great summary on CD-12 timeline expectations by "Hulk" on the Yahoo board:
"Just want to share some industry knowledge regarding timelines after speaking with a trial statistician who leads trial design in multiple pharmaceutical companies.
Basically three milestones after LPLV (last patient last visit). LPLV for CD10 is 14 days after enrollment and CD12 is 28 days after full enrollment.
1. Database Lock - 6 weeks. This involves all the 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 - 1 week. This step could be faster if everything goes as planned but typically targeted for a week allow some wiggle room.
3. Top line report - 1 week.
BTW interim analysis typically goes faster as it’s more of identifying a trend and not all data are needed.
So 8 weeks after LPLV should be the typical time to expect top line report. I found 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. As much as I dislike Amrex they were ahead of industry standards for CD10.
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. If Amrex performs at same speed as in CD10, we would be looking at the topline report on 3/1.
There are a lot of guess why no news yet, well, my theory is nobody has verified data to do any analysis just yet. Even if FDA requested raw data from Amrex directly, they won’t get it until database lock which I expect to happen some time next week.
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