Request for additional clinical data on primary endpoint
Correspondence from ANMAT regarding ANMAT-2020-0075. Type: deficiency. Risk: low. Category: Nonclinical.
Correspondence ID
COR-475
Type
deficiency
Application
Authority
ANMAT
Category
Nonclinical
Risk
Low
Due Date
2025-02-25
Status
Overdue
Owner
James O'Brien
Created
2023-12-07
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0075, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.