Request for additional clinical data on primary endpoint

Correspondence from Therapeutic Goods Administration regarding TGA-2023-0007. Type: information-request. Risk: medium. Category: Administrative.

Correspondence ID
COR-107
Type
information-request
Application
TGA-2023-0007
Authority
Therapeutic Goods Administration
Category
Administrative
Risk
Medium
Due Date
2025-04-06
Status
Completed
Owner
Priya Sharma
Created
2022-10-06
Correspondence Body
Dear TGA Review Team, With reference to application TGA-2023-0007, we wish to address the following: [Detailed response body regarding request for post-marketing commitment progress update] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_107_1.pdf
Response Package
Response package assembled: RP-107