BLA Submission Plan 45
This submission plan coordinates owners, milestone dependencies, and readiness controls for Haemovance. 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-045
Application
Target Date
2025-04-27
Status
Approved
Owner
Marcus Webb
Created
2022-07-30
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
9 components are missing approval snapshots.
6 components still have unresolved review comments.
GMP inspection findings to be resolved
Quality review gate not passed
Milestone Dependency Strip
Regulatory review
Module 3 update
Quality review
Data cutoff
Authority acknowledgement expected
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Regulatory review | 2025-01-15 | Nadia Petrova | None | Independent | No |
| Module 3 update | 2025-03-17 | Tomoko Ikeda | PLAN-045-MS-001 | Dependent | Yes |
| Quality review | 2025-04-11 | Priya Sharma | None | Independent | No |
| Data cutoff | 2025-04-09 | Dmitri Volkov | PLAN-045-MS-003 | Dependent | Yes |
| Authority acknowledgement expected | 2025-06-02 | Aisha Okonkwo | PLAN-045-MS-004 | Dependent | Yes |