Type IA Variation Submission Plan 24
This submission plan coordinates owners, milestone dependencies, and readiness controls for Semaglumax. Teams use it to monitor timeline health, resolve blockers, and decide whether content is publish-ready for sequence assembly. Readiness is calculated from deterministic component approval status across linked dossiers, rather than manual estimates. Use the edit and content assembly actions to move directly into corrective work.
Plan ID
PLAN-024
Application
Target Date
2025-09-15
Status
Submitted
Owner
Dmitri Volkov
Created
2022-07-16
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
9 components are missing approval snapshots.
5 components still have unresolved review comments.
Milestone Dependency Strip
Authority acknowledgement expected
Protocol finalization
QC check
Publishing start
Data cutoff
Regulatory review
CSR review
Dispatch submission
Statistical analysis plan lock
Module 5 compilation
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Authority acknowledgement expected | 2025-02-02 | Carlos Mendez | None | Independent | No |
| Protocol finalization | 2025-03-17 | Lieselotte van der Berg | None | Independent | Yes |
| QC check | 2025-04-15 | Priya Sharma | PLAN-024-MS-002 | Dependent | No |
| Publishing start | 2025-04-28 | Aisha Okonkwo | None | Independent | No |
| Data cutoff | 2025-06-18 | Carlos Mendez | PLAN-024-MS-004 | Dependent | Yes |
| Regulatory review | 2025-07-11 | Nadia Petrova | PLAN-024-MS-005 | Dependent | No |
| CSR review | 2025-07-25 | Carlos Mendez | PLAN-024-MS-006 | Dependent | Yes |
| Dispatch submission | 2025-07-30 | Priya Sharma | None | Independent | No |
| Statistical analysis plan lock | 2025-09-06 | Aisha Okonkwo | None | Independent | No |
| Module 5 compilation | 2025-09-13 | James O'Brien | PLAN-024-MS-009 | Dependent | No |