NDA Submission Plan 13
This submission plan coordinates owners, milestone dependencies, and readiness controls for Tiotropex. 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-013
Application
Target Date
2025-12-21
Status
Approved
Owner
Priya Sharma
Created
2022-02-22
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
9 components are missing approval snapshots.
4 components still have unresolved review comments.
GMP inspection findings to be resolved
Authority clarification needed on comparator study
Publishing tool version upgrade in progress
Milestone Dependency Strip
Dispatch submission
Authority acknowledgement expected
Protocol finalization
Regulatory review
Publishing start
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Dispatch submission | 2025-02-16 | Priya Sharma | None | Independent | No |
| Authority acknowledgement expected | 2025-03-24 | Aisha Okonkwo | None | Independent | Yes |
| Protocol finalization | 2025-04-14 | Nadia Petrova | PLAN-013-MS-002 | Dependent | No |
| Regulatory review | 2025-05-23 | Lieselotte van der Berg | None | Independent | No |
| Publishing start | 2025-06-22 | Nadia Petrova | PLAN-013-MS-004 | Dependent | No |