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.
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