Positive FDA Feedback on NDA Submission Process for TLX591-CDx (kit for the preparation of 68Ga-PSMA-11)
Melbourne (Australia) – 25 Feb 2020. Telix Pharmaceuticals announces that it has received positive feedback from the FDA regarding its submission of an NDA for TLX591-CDx
Telix Pharmaceuticals Limited is pleased to announce that it has received positive feedback from the US Food and Drug Administration (FDA) regarding its submission of a New Drug Application (NDA) for TLX591-CDx (kit for the preparation of 68Ga-PSMA-11).
Telix’s clinical data proposed for its NDA submission is based on a combination of prospective and retrospective data, including imaging data from the Novartis VISION study. The FDA has provided detailed feedback on the clinical briefing package for the efficacy data, which the Company expects to be able to satisfy, based on the planned submission dataset.
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