Countdown Clock Clicks Closer to " End of July "
Extract from this Release:
Telix is progressing multiple marketing authorisation applications across its precision medicine (diagnostic) portfolio, including:
• New Drug Application (NDA) submission for new prostate cancer imaging agent TLX007-CDx (PSMA-PET imaging5 ):
Telix submitted a NDA to the FDA for a new PSMA targeting prostate cancer imaging agent designed to expand the availability, distribution and
scheduling flexibility for PSMA-PET imaging6
. The FDA is expected to confirm by the end of July 2024 whether the submission is accepted for review.
Confirmation of the PDUFA7 goal date (review timeframe) is expected in early August 2024, in line with FDA procedure.
Ann: Telix Q2 2024 Revenue/Business Highlights, Guidance Upgrade, page-53
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