sNDA Submission Plan 54

Open Content Assembly

This submission plan coordinates owners, milestone dependencies, and readiness controls for Semaglumax. 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-054
Application
COFEPRIS-2021-0054
Target Date
2025-10-04
Status
Blocked
Owner
Aisha Okonkwo
Created
2022-10-17
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
9 components are missing approval snapshots.
6 components still have unresolved review comments.
Milestone Dependency Strip
Module 5 compilation
Publishing start
Quality review
CSR draft
QC check
MilestoneDue DateOwnerDependenciesDependency IndicatorsCompleted
Module 5 compilation2025-01-20Nadia PetrovaNoneIndependentNo
Publishing start2025-03-18Lieselotte van der BergPLAN-054-MS-001DependentYes
Quality review2025-04-08Dmitri VolkovPLAN-054-MS-002DependentNo
CSR draft2025-05-23Nadia PetrovaPLAN-054-MS-003DependentYes
QC check2025-07-01James O'BrienPLAN-054-MS-004DependentNo