sNDA Submission Plan 12
This submission plan coordinates owners, milestone dependencies, and readiness controls for Respimax. 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-012
Application
Target Date
2025-02-13
Status
Failed
Owner
Sarah Chen
Created
2022-03-28
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
10 components are missing approval snapshots.
2 components still have unresolved review comments.
Milestone Dependency Strip
CSR draft
Dispatch submission
Protocol finalization
CSR review
Module 3 update
Authority acknowledgement expected
Data cutoff
QC check
Quality review
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| CSR draft | 2025-02-05 | James O'Brien | None | Independent | No |
| Dispatch submission | 2025-02-28 | Aisha Okonkwo | PLAN-012-MS-001 | Dependent | Yes |
| Protocol finalization | 2025-04-01 | Aisha Okonkwo | None | Independent | No |
| CSR review | 2025-04-30 | Tomoko Ikeda | PLAN-012-MS-003 | Dependent | Yes |
| Module 3 update | 2025-06-02 | Lieselotte van der Berg | PLAN-012-MS-004 | Dependent | Yes |
| Authority acknowledgement expected | 2025-07-15 | James O'Brien | None | Independent | Yes |
| Data cutoff | 2025-07-29 | Nadia Petrova | PLAN-012-MS-006 | Dependent | No |
| QC check | 2025-08-20 | Sarah Chen | None | Independent | No |
| Quality review | 2025-09-20 | Carlos Mendez | PLAN-012-MS-008 | Dependent | Yes |