BLA Submission Plan 40
This submission plan coordinates owners, milestone dependencies, and readiness controls for Fabricor. 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-040
Application
Target Date
2025-03-20
Status
Approved
Owner
Lieselotte van der Berg
Created
2022-05-22
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
8 components are missing approval snapshots.
5 components still have unresolved review comments.
GMP inspection findings to be resolved
Publishing tool version upgrade in progress
Module 5 CSR review pending sign-off
Milestone Dependency Strip
Regulatory review
QC check
Authority acknowledgement expected
Publishing start
Dispatch submission
Statistical analysis plan lock
Data cutoff
Protocol finalization
Quality review
CSR draft
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Regulatory review | 2025-01-20 | Lieselotte van der Berg | None | Independent | Yes |
| QC check | 2025-02-14 | Priya Sharma | None | Independent | No |
| Authority acknowledgement expected | 2025-03-27 | Aisha Okonkwo | None | Independent | No |
| Publishing start | 2025-04-12 | Nadia Petrova | PLAN-040-MS-003 | Dependent | No |
| Dispatch submission | 2025-04-26 | Aisha Okonkwo | PLAN-040-MS-004 | Dependent | No |
| Statistical analysis plan lock | 2025-06-09 | Lieselotte van der Berg | None | Independent | Yes |
| Data cutoff | 2025-06-20 | Nadia Petrova | PLAN-040-MS-006 | Dependent | No |
| Protocol finalization | 2025-07-02 | Aisha Okonkwo | PLAN-040-MS-007 | Dependent | Yes |
| Quality review | 2025-08-05 | James O'Brien | None | Independent | Yes |
| CSR draft | 2025-08-20 | Marcus Webb | PLAN-040-MS-009 | Dependent | No |