Telix Pharmaceuticals (US) Inc.: BLA 761401

We acknowledge receipt of your CMC amendment dated August 18, 2025, which was not reviewed for this action.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response to your application.

Your complete response should include the date(s) of the facility's response to the FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.

Following a CGMP inspection and pre-license inspection (PLI) of isted in this application, convey: leficiencies to representative of the facility.

Evidence provided as confirmatory evidence of effectiveness was not sufficiently strong to complement study 18F-TLX101-CDx-203. Four studies were examined as confirmatory evidence, including one re-read of images obtained from expanded access use of floretyrosine F 18, GBM-RET-01, and three published retrospective studies.