sBLA Submission Plan 38
This submission plan coordinates owners, milestone dependencies, and readiness controls for Alzaclear. 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-038
Application
Target Date
2025-04-15
Status
Blocked
Owner
Nadia Petrova
Created
2022-07-16
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
5 components are missing approval snapshots.
6 components still have unresolved review comments.
Cross-market label harmonisation open
Phase III data reconciliation ongoing
Awaiting CMC stability data lock
Milestone Dependency Strip
Authority acknowledgement expected
CSR draft
QC check
Protocol finalization
Regulatory review
Module 3 update
Publishing start
Module 5 compilation
CSR review
Data cutoff
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Authority acknowledgement expected | 2025-01-27 | Priya Sharma | None | Independent | Yes |
| CSR draft | 2025-02-19 | Sarah Chen | PLAN-038-MS-001 | Dependent | No |
| QC check | 2025-03-10 | Nadia Petrova | None | Independent | Yes |
| Protocol finalization | 2025-03-27 | Tomoko Ikeda | None | Independent | No |
| Regulatory review | 2025-05-14 | Nadia Petrova | None | Independent | Yes |
| Module 3 update | 2025-05-30 | Tomoko Ikeda | None | Independent | No |
| Publishing start | 2025-06-30 | James O'Brien | PLAN-038-MS-006 | Dependent | Yes |
| Module 5 compilation | 2025-07-12 | James O'Brien | None | Independent | Yes |
| CSR review | 2025-08-22 | Nadia Petrova | None | Independent | Yes |
| Data cutoff | 2025-09-22 | Sarah Chen | None | Independent | Yes |