sBLA Submission Plan 32
This submission plan coordinates owners, milestone dependencies, and readiness controls for Verasol. 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-032
Application
Target Date
2025-10-02
Status
Completed
Owner
James O'Brien
Created
2022-02-18
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
6 components are missing approval snapshots.
5 components still have unresolved review comments.
Milestone Dependency Strip
CSR draft
Statistical analysis plan lock
Regulatory review
Quality review
Data cutoff
QC check
Module 3 update
Publishing start
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| CSR draft | 2025-01-31 | Nadia Petrova | None | Independent | No |
| Statistical analysis plan lock | 2025-02-09 | Sarah Chen | None | Independent | No |
| Regulatory review | 2025-03-12 | Aisha Okonkwo | None | Independent | No |
| Quality review | 2025-04-05 | James O'Brien | None | Independent | No |
| Data cutoff | 2025-05-03 | Marcus Webb | None | Independent | No |
| QC check | 2025-06-14 | James O'Brien | None | Independent | No |
| Module 3 update | 2025-07-21 | Aisha Okonkwo | None | Independent | Yes |
| Publishing start | 2025-08-29 | Aisha Okonkwo | PLAN-032-MS-007 | Dependent | No |