sBLA Submission Plan 21
This submission plan coordinates owners, milestone dependencies, and readiness controls for Lorlacor. 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-021
Application
Target Date
2025-11-02
Status
In Progress
Owner
Aisha Okonkwo
Created
2023-01-27
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
11 components are missing approval snapshots.
3 components still have unresolved review comments.
Milestone Dependency Strip
Module 5 compilation
Publishing start
Module 3 update
Data cutoff
Protocol finalization
Statistical analysis plan lock
Regulatory review
Authority acknowledgement expected
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Module 5 compilation | 2025-02-10 | Tomoko Ikeda | None | Independent | Yes |
| Publishing start | 2025-03-05 | Priya Sharma | None | Independent | Yes |
| Module 3 update | 2025-03-30 | Dmitri Volkov | None | Independent | No |
| Data cutoff | 2025-04-04 | James O'Brien | None | Independent | No |
| Protocol finalization | 2025-05-06 | Nadia Petrova | PLAN-021-MS-004 | Dependent | No |
| Statistical analysis plan lock | 2025-05-30 | Aisha Okonkwo | None | Independent | Yes |
| Regulatory review | 2025-07-13 | Tomoko Ikeda | PLAN-021-MS-006 | Dependent | No |
| Authority acknowledgement expected | 2025-09-02 | James O'Brien | None | Independent | Yes |