Type II Variation Submission Plan 49
This submission plan coordinates owners, milestone dependencies, and readiness controls for Brexivance. 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-049
Application
Target Date
2025-10-03
Status
Failed
Owner
Sarah Chen
Created
2022-02-03
Readiness Score
0/100
Calculated from 0 approved of 20 linked content components.
Blockers
10 components are missing approval snapshots.
3 components still have unresolved review comments.
Cross-market label harmonisation open
Phase III data reconciliation ongoing
Authority clarification needed on comparator study
Milestone Dependency Strip
CSR review
CSR draft
Publishing start
Module 5 compilation
Authority acknowledgement expected
Protocol finalization
Module 3 update
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| CSR review | 2025-01-18 | Lieselotte van der Berg | None | Independent | Yes |
| CSR draft | 2025-02-10 | Carlos Mendez | None | Independent | No |
| Publishing start | 2025-03-18 | Marcus Webb | PLAN-049-MS-002 | Dependent | Yes |
| Module 5 compilation | 2025-04-27 | Tomoko Ikeda | None | Independent | Yes |
| Authority acknowledgement expected | 2025-06-16 | Lieselotte van der Berg | PLAN-049-MS-004 | Dependent | No |
| Protocol finalization | 2025-06-27 | Marcus Webb | None | Independent | No |
| Module 3 update | 2025-07-29 | Sarah Chen | None | Independent | Yes |