MAA Submission Plan 9
This submission plan coordinates owners, milestone dependencies, and readiness controls for Raredex. 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-009
Application
Target Date
2025-12-08
Status
Active
Owner
James O'Brien
Created
2022-06-17
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
10 components are missing approval snapshots.
4 components still have unresolved review comments.
GMP inspection findings to be resolved
Phase III data reconciliation ongoing
Publishing tool version upgrade in progress
Milestone Dependency Strip
Dispatch submission
Quality review
CSR review
Authority acknowledgement expected
Publishing start
Data cutoff
Module 5 compilation
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Dispatch submission | 2025-02-14 | James O'Brien | None | Independent | No |
| Quality review | 2025-02-24 | Lieselotte van der Berg | PLAN-009-MS-001 | Dependent | Yes |
| CSR review | 2025-03-27 | James O'Brien | PLAN-009-MS-002 | Dependent | No |
| Authority acknowledgement expected | 2025-04-30 | Dmitri Volkov | None | Independent | No |
| Publishing start | 2025-06-21 | Carlos Mendez | None | Independent | Yes |
| Data cutoff | 2025-07-02 | James O'Brien | None | Independent | Yes |
| Module 5 compilation | 2025-08-05 | Lieselotte van der Berg | None | Independent | Yes |