Telix Pharmaceuticals Limited announced that the U.S. Food and Drug Administration (`FDA', the `Agency') has extended the review period for the Company's New Drug Application (NDA) for its prostate cancer imaging investigational product Illuccix® (TLX591-CDx, kit for the preparation of 68Ga-PSMA-11 injection) by three months. The revised target Prescription Drug User Fee Act (PDUFA) goal date of 23 December 2021 will allow the FDA to review and consider further manufacturing-related information submitted by the Company and conclude the label review. This is a standard review extension period. Telix attended a late-cycle review meeting with the FDA on the 17 June 2021. During the meeting, the FDA indicated that there were no outstanding substantive manufacturing or clinical review issues with Telix's submission. 1 However, the Company's Pre-Authorisation Inspection (PAI) fell subsequent to the late-cycle review meeting and raised a well-defined set of manufacturing-related observations. The Company has fully responded to those observations and the FDA is currently reviewing.