Type IB Variation Submission Plan 33

Open Content Assembly

This submission plan coordinates owners, milestone dependencies, and readiness controls for Cardivex. 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-033
Application
CDSCO-2022-0033
Target Date
2025-02-23
Status
Submitted
Owner
Marcus Webb
Created
2022-02-17
Readiness Score
20/100
Calculated from 4 approved of 20 linked content components.
Blockers
9 components are missing approval snapshots.
2 components still have unresolved review comments.
Awaiting CMC stability data lock
Module 5 CSR review pending sign-off
GMP inspection findings to be resolved
Milestone Dependency Strip
Module 5 compilation
CSR draft
Dispatch submission
CSR review
Regulatory review
Protocol finalization
QC check
Data cutoff
MilestoneDue DateOwnerDependenciesDependency IndicatorsCompleted
Module 5 compilation2025-01-24Aisha OkonkwoNoneIndependentNo
CSR draft2025-03-22Priya SharmaPLAN-033-MS-001DependentYes
Dispatch submission2025-05-01James O'BrienNoneIndependentNo
CSR review2025-05-17Priya SharmaNoneIndependentNo
Regulatory review2025-06-07Lieselotte van der BergPLAN-033-MS-004DependentNo
Protocol finalization2025-07-03Dmitri VolkovPLAN-033-MS-005DependentYes
QC check2025-08-17Nadia PetrovaNoneIndependentNo
Data cutoff2025-09-23Lieselotte van der BergPLAN-033-MS-007DependentYes