From the 4Q 2023 report:
"Preparation of a Biologics License Application (BLA) and commercialisation of TLX250-CDx (89Zr-DFO-girentuximab), Telix’s investigational kidney cancer imaging agent: As supported under the Breakthrough Therapydesignation, the Company is actively engaging with the FDA as it prepares its regulatory filing. The Companyparticipated in a Type B meeting with the agency during the quarter. Based on this positive discussion the Companycontinues to progress its BLA submission in 2023 as planned."
Submission in 2023. Approval????
From https://my.clevelandclinic.org/health/diseases/22273-clear-cell-renal-cell-carcinoma there are about 76000 new cases of kidney cancer diagnosed in the US a year with about 8 in 10 being ccRCC. If you use the AUS$5k scan price for Kidney cancer then that would be a market of AUS$380m. While TLX250-CDx is superior to the current standard of care it will be difficult to gauge the take up until we get a couple of quarters of sales.
Cheers
Understanding Telix, page-166
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