News

FDA Pre-NDA Meeting Outcomes : TLX591-CDx (illumet™)

MELBOURNE (Australia) and INDIANAPOLIS (USA) – 28 August 2019. Telix had a pre-NDA meeting with the United States Food and Drug Administration (FDA) on the 24th of July to discuss the Company’s plan

Melbourne (Australia) and Indianapolis (USA) – Aug. 28, 2019

Telix had a pre-NDA meeting with the United States Food and Drug Administration (FDA) on the 24th of July to discuss the Company’s plan for the submission of a New Drug Application (NDA) for TLX591-CDx, (kit for the preparation of 68Ga-PSMA, trademarked as illumet™ in the United States). The Company has now received the formal meeting minutes from the FDA and can reliably report on the outcomes.

To read the full media release click here.