sBLA Submission Plan 19
This submission plan coordinates owners, milestone dependencies, and readiness controls for Brexivance. 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-019
Application
Target Date
2025-12-11
Status
In Progress
Owner
Nadia Petrova
Created
2022-11-14
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
11 components are missing approval snapshots.
1 components still have unresolved review comments.
Milestone Dependency Strip
Regulatory review
CSR review
Publishing start
Quality review
Dispatch submission
QC check
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Regulatory review | 2025-02-02 | Marcus Webb | None | Independent | Yes |
| CSR review | 2025-02-17 | Priya Sharma | None | Independent | No |
| Publishing start | 2025-03-19 | Priya Sharma | None | Independent | No |
| Quality review | 2025-04-22 | Marcus Webb | PLAN-019-MS-003 | Dependent | No |
| Dispatch submission | 2025-05-26 | Tomoko Ikeda | PLAN-019-MS-004 | Dependent | No |
| QC check | 2025-06-11 | Sarah Chen | PLAN-019-MS-005 | Dependent | No |