Request for additional clinical data on primary endpoint
Correspondence from ANMAT regarding ANMAT-2020-0035. Type: query. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-435
Type
query
Application
Authority
ANMAT
Category
Nonclinical
Risk
Medium
Due Date
2024-12-11
Status
Draft
Owner
Lieselotte van der Berg
Created
2022-10-04
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0035, 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
Attachments
data_table_435.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.