sBLA Submission Plan 31
This submission plan coordinates owners, milestone dependencies, and readiness controls for Ocluvance. 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-031
Application
Target Date
2025-11-07
Status
Submitted
Owner
Marcus Webb
Created
2022-07-06
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
6 components are missing approval snapshots.
4 components still have unresolved review comments.
Milestone Dependency Strip
CSR draft
Authority acknowledgement expected
Publishing start
Quality review
Module 5 compilation
Protocol finalization
Data cutoff
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| CSR draft | 2025-02-08 | Priya Sharma | None | Independent | No |
| Authority acknowledgement expected | 2025-03-08 | Tomoko Ikeda | None | Independent | Yes |
| Publishing start | 2025-04-20 | Dmitri Volkov | PLAN-031-MS-002 | Dependent | Yes |
| Quality review | 2025-05-12 | Priya Sharma | PLAN-031-MS-003 | Dependent | Yes |
| Module 5 compilation | 2025-06-18 | Nadia Petrova | PLAN-031-MS-004 | Dependent | No |
| Protocol finalization | 2025-07-09 | Sarah Chen | None | Independent | No |
| Data cutoff | 2025-07-31 | Carlos Mendez | None | Independent | No |