sBLA Submission Plan 16
This submission plan coordinates owners, milestone dependencies, and readiness controls for Retinacor. 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-016
Application
Target Date
2025-10-21
Status
Approved
Owner
Carlos Mendez
Created
2022-09-18
Readiness Score
20/100
Calculated from 4 approved of 20 linked content components.
Blockers
8 components are missing approval snapshots.
3 components still have unresolved review comments.
Milestone Dependency Strip
Protocol finalization
Publishing start
Module 5 compilation
Regulatory review
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Protocol finalization | 2025-02-12 | Tomoko Ikeda | None | Independent | Yes |
| Publishing start | 2025-03-20 | Lieselotte van der Berg | PLAN-016-MS-001 | Dependent | No |
| Module 5 compilation | 2025-04-02 | Aisha Okonkwo | PLAN-016-MS-002 | Dependent | Yes |
| Regulatory review | 2025-05-16 | Nadia Petrova | PLAN-016-MS-003 | Dependent | No |