sMAA Submission Plan 30

Open Content Assembly

This submission plan coordinates owners, milestone dependencies, and readiness controls for Mavacor. 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-030
Application
MFDS-2020-0030
Target Date
2025-02-10
Status
Pending
Owner
Sarah Chen
Created
2022-11-15
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
7 components are missing approval snapshots.
3 components still have unresolved review comments.
Awaiting CMC stability data lock
Cross-market label harmonisation open
Milestone Dependency Strip
QC check
Dispatch submission
Quality review
Module 3 update
CSR review
Statistical analysis plan lock
Publishing start
CSR draft
Protocol finalization
Regulatory review
MilestoneDue DateOwnerDependenciesDependency IndicatorsCompleted
QC check2025-02-02Lieselotte van der BergNoneIndependentNo
Dispatch submission2025-02-20Priya SharmaPLAN-030-MS-001DependentYes
Quality review2025-02-21Carlos MendezPLAN-030-MS-002DependentYes
Module 3 update2025-04-11Priya SharmaPLAN-030-MS-003DependentNo
CSR review2025-06-03Lieselotte van der BergPLAN-030-MS-004DependentNo
Statistical analysis plan lock2025-07-09Nadia PetrovaNoneIndependentYes
Publishing start2025-07-23Tomoko IkedaNoneIndependentNo
CSR draft2025-08-19Lieselotte van der BergPLAN-030-MS-007DependentYes
Protocol finalization2025-09-14Tomoko IkedaNoneIndependentYes
Regulatory review2025-10-19Carlos MendezPLAN-030-MS-009DependentNo