Label Update Submission Plan 143

Open Content Assembly

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-143
Application
PMDA-2022-0043
Target Date
2025-07-05
Status
Blocked
Owner
Dmitri Volkov
Created
2022-11-10
Readiness Score
15/100
Calculated from 3 approved of 20 linked content components.
Blockers
9 components are missing approval snapshots.
5 components still have unresolved review comments.
Milestone Dependency Strip
CSR draft
Module 5 compilation
Regulatory review
Authority acknowledgement expected
CSR review
Data cutoff
Publishing start
Protocol finalization
Statistical analysis plan lock
MilestoneDue DateOwnerDependenciesDependency IndicatorsCompleted
CSR draft2025-01-15Nadia PetrovaNoneIndependentNo
Module 5 compilation2025-02-16Carlos MendezPLAN-143-MS-001DependentYes
Regulatory review2025-03-27Tomoko IkedaNoneIndependentNo
Authority acknowledgement expected2025-04-21James O'BrienNoneIndependentYes
CSR review2025-05-06Aisha OkonkwoPLAN-143-MS-004DependentYes
Data cutoff2025-05-28Aisha OkonkwoPLAN-143-MS-005DependentYes
Publishing start2025-07-07Sarah ChenNoneIndependentNo
Protocol finalization2025-07-18Lieselotte van der BergNoneIndependentYes
Statistical analysis plan lock2025-09-05Dmitri VolkovNoneIndependentNo