Type IB Variation Submission Plan 11

Open Content Assembly

This submission plan coordinates owners, milestone dependencies, and readiness controls for Infeclear. 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-011
Application
TFDA-2024-0011
Target Date
2025-06-05
Status
Overdue
Owner
Lieselotte van der Berg
Created
2022-06-30
Readiness Score
5/100
Calculated from 1 approved of 20 linked content components.
Blockers
6 components are missing approval snapshots.
4 components still have unresolved review comments.
Awaiting CMC stability data lock
Milestone Dependency Strip
CSR review
QC check
Regulatory review
Data cutoff
Dispatch submission
Statistical analysis plan lock
Module 3 update
Publishing start
MilestoneDue DateOwnerDependenciesDependency IndicatorsCompleted
CSR review2025-01-22Priya SharmaNoneIndependentYes
QC check2025-02-13Dmitri VolkovNoneIndependentNo
Regulatory review2025-03-13Carlos MendezNoneIndependentNo
Data cutoff2025-03-29Tomoko IkedaNoneIndependentNo
Dispatch submission2025-04-14Sarah ChenNoneIndependentYes
Statistical analysis plan lock2025-05-24Sarah ChenNoneIndependentYes
Module 3 update2025-07-11Carlos MendezPLAN-011-MS-006DependentYes
Publishing start2025-08-05Dmitri VolkovNoneIndependentNo