sNDA Submission Plan 41
This submission plan coordinates owners, milestone dependencies, and readiness controls for Infeclear. 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-041
Application
Target Date
2025-10-04
Status
Completed
Owner
Lieselotte van der Berg
Created
2022-07-02
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
6 components are missing approval snapshots.
5 components still have unresolved review comments.
GMP inspection findings to be resolved
Milestone Dependency Strip
Publishing start
CSR review
Regulatory review
Module 5 compilation
Module 3 update
Authority acknowledgement expected
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Publishing start | 2025-01-25 | Sarah Chen | None | Independent | No |
| CSR review | 2025-01-29 | Priya Sharma | PLAN-041-MS-001 | Dependent | Yes |
| Regulatory review | 2025-02-23 | Carlos Mendez | PLAN-041-MS-002 | Dependent | No |
| Module 5 compilation | 2025-03-09 | Tomoko Ikeda | PLAN-041-MS-003 | Dependent | Yes |
| Module 3 update | 2025-04-06 | Sarah Chen | PLAN-041-MS-004 | Dependent | Yes |
| Authority acknowledgement expected | 2025-04-22 | Nadia Petrova | None | Independent | No |