Question · H2 2025
Melissa Benson inquired about the agreed deliverables with the FDA for the Zircaix BLA resubmission, specifically whether new clinical data is required or if the focus is on preclinical and analytical data.
Answer
Christian Behrenbruch, CEO and Managing Director of Telix Pharmaceuticals, stated that most CMC remediation topics involve laboratory, manufacturing, and process documentation. He confirmed that a deliverable regarding comparability between research-grade and commercial-scale material is well in hand and not a material time delay, implying no new clinical data is required.
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