sBLA Submission Plan 121
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-121
Application
Target Date
2025-10-02
Status
Submitted
Owner
Dmitri Volkov
Created
2022-05-11
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.
Phase III data reconciliation ongoing
Awaiting CMC stability data lock
Quality review gate not passed
Milestone Dependency Strip
CSR review
Statistical analysis plan lock
Data cutoff
Dispatch submission
Module 3 update
Publishing start
Module 5 compilation
Quality review
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| CSR review | 2025-01-14 | Marcus Webb | None | Independent | No |
| Statistical analysis plan lock | 2025-02-15 | Priya Sharma | None | Independent | Yes |
| Data cutoff | 2025-03-07 | Aisha Okonkwo | None | Independent | No |
| Dispatch submission | 2025-03-18 | James O'Brien | PLAN-121-MS-003 | Dependent | No |
| Module 3 update | 2025-04-18 | Priya Sharma | PLAN-121-MS-004 | Dependent | No |
| Publishing start | 2025-05-22 | Carlos Mendez | None | Independent | No |
| Module 5 compilation | 2025-06-10 | Sarah Chen | PLAN-121-MS-006 | Dependent | No |
| Quality review | 2025-07-11 | Tomoko Ikeda | PLAN-121-MS-007 | Dependent | No |