NDS Submission Plan 51
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-051
Application
Target Date
2025-09-30
Status
Blocked
Owner
Lieselotte van der Berg
Created
2022-05-05
Readiness Score
5/100
Calculated from 1 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
Cross-market label harmonisation open
Phase III data reconciliation ongoing
Milestone Dependency Strip
Regulatory review
Quality review
Authority acknowledgement expected
CSR draft
Protocol finalization
Data cutoff
Module 3 update
Statistical analysis plan lock
QC check
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Regulatory review | 2025-01-13 | Lieselotte van der Berg | None | Independent | No |
| Quality review | 2025-03-09 | Aisha Okonkwo | None | Independent | No |
| Authority acknowledgement expected | 2025-03-14 | Marcus Webb | PLAN-051-MS-002 | Dependent | No |
| CSR draft | 2025-04-08 | Marcus Webb | PLAN-051-MS-003 | Dependent | No |
| Protocol finalization | 2025-05-14 | Carlos Mendez | PLAN-051-MS-004 | Dependent | Yes |
| Data cutoff | 2025-07-03 | Tomoko Ikeda | PLAN-051-MS-005 | Dependent | Yes |
| Module 3 update | 2025-08-05 | Nadia Petrova | PLAN-051-MS-006 | Dependent | Yes |
| Statistical analysis plan lock | 2025-09-17 | Nadia Petrova | PLAN-051-MS-007 | Dependent | No |
| QC check | 2025-10-23 | Lieselotte van der Berg | PLAN-051-MS-008 | Dependent | Yes |