Request for additional clinical data on primary endpoint
Correspondence from Health Canada regarding HC-2024-0046. Type: question. Risk: low. Category: Administrative.
Correspondence ID
COR-046
Type
question
Application
Authority
Health Canada
Category
Administrative
Risk
Low
Due Date
2025-03-09
Status
Open
Owner
Dmitri Volkov
Created
2023-06-25
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0046, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_46_1.pdfdata_table_46.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.