Sydney, Australia – 29 May 2023 – Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to announce that it has completed a positive pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for F18-pivalate (RAD 101).
This is a significant milestone towards our IND application for our late stage clinical trials. Based on positive guidance received from the U.S. FDA, the Company will file an IND application to initiate a multi-center trial for imaging brain metastasis during the third quarter of 2023 and anticipates having the first patient dosed by the end of the year.
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