Some people would benefit greatly from enhancing their reading comprehension skills...
Telix is expected to address these concerns within 90 days and resubmit the application. The FDA has not found any issues with the clinical or nonclinical data regarding the safety or efficacy of TLX250-CDx.
Telix plans to request a meeting with the FDA to discuss the feedback and necessary amendments. They aim to complete the required actions and resubmit the BLA to reach a full U.S. commercial launch in 2025.
The delay is considered non-material, meaning it won’t affect their 2024 revenue or R&D expenditure forecasts, which remain unchanged.
TLX250-CDx is a promising imaging agent for renal cancer, and Telix’s commitment to resolving these issues demonstrates their dedication to bringing this breakthrough product to market.
Some people would benefit greatly from enhancing their reading...
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