MAA Submission Plan 22
This submission plan coordinates owners, milestone dependencies, and readiness controls for Sacuvance. 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-022
Application
Target Date
2025-09-09
Status
Completed
Owner
Nadia Petrova
Created
2022-03-13
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
7 components are missing approval snapshots.
6 components still have unresolved review comments.
GMP inspection findings to be resolved
Module 5 CSR review pending sign-off
Cross-market label harmonisation open
Milestone Dependency Strip
CSR review
Data cutoff
Statistical analysis plan lock
Module 3 update
Authority acknowledgement expected
QC check
Publishing start
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| CSR review | 2025-02-05 | James O'Brien | None | Independent | Yes |
| Data cutoff | 2025-03-24 | Tomoko Ikeda | PLAN-022-MS-001 | Dependent | No |
| Statistical analysis plan lock | 2025-03-23 | Tomoko Ikeda | PLAN-022-MS-002 | Dependent | No |
| Module 3 update | 2025-04-12 | Marcus Webb | PLAN-022-MS-003 | Dependent | Yes |
| Authority acknowledgement expected | 2025-05-05 | Dmitri Volkov | PLAN-022-MS-004 | Dependent | No |
| QC check | 2025-06-18 | Nadia Petrova | PLAN-022-MS-005 | Dependent | Yes |
| Publishing start | 2025-07-19 | Aisha Okonkwo | PLAN-022-MS-006 | Dependent | Yes |