FDA Pre-NDA Meeting Outcomes : TLX591-CDx (illumet™)
MELBOURNE (Australia) and INDIANAPOLIS (USA) – 28 August 2019. Telix had a pre-NDA meeting with the FDA to discuss the Company’s plan for submission of NDA for TLX591-CDx
Telix is pleased to share the company 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 please click here.
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