sMAA Submission Plan 50
This submission plan coordinates owners, milestone dependencies, and readiness controls for Erenvex. 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-050
Application
Target Date
2025-08-13
Status
Approved
Owner
James O'Brien
Created
2022-09-01
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
12 components are missing approval snapshots.
5 components still have unresolved review comments.
GMP inspection findings to be resolved
Awaiting CMC stability data lock
Milestone Dependency Strip
Quality review
Module 3 update
QC check
CSR draft
Authority acknowledgement expected
CSR review
Data cutoff
Statistical analysis plan lock
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Quality review | 2025-01-15 | Carlos Mendez | None | Independent | No |
| Module 3 update | 2025-02-09 | Marcus Webb | PLAN-050-MS-001 | Dependent | No |
| QC check | 2025-03-24 | Priya Sharma | PLAN-050-MS-002 | Dependent | Yes |
| CSR draft | 2025-04-09 | Aisha Okonkwo | None | Independent | No |
| Authority acknowledgement expected | 2025-05-03 | Marcus Webb | None | Independent | Yes |
| CSR review | 2025-06-07 | Priya Sharma | PLAN-050-MS-005 | Dependent | Yes |
| Data cutoff | 2025-07-03 | Carlos Mendez | None | Independent | No |
| Statistical analysis plan lock | 2025-07-30 | Tomoko Ikeda | PLAN-050-MS-007 | Dependent | No |