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12/12/22 6:45 PM

#154178 RE: dekeferrell #154176

Ain't no big picture without Radiogel in human trials. Where's that IDE application that was supposed to be submitted almost 15 months ago? Rabbit tests haven't even started. Then what if containment isn't 100%? I'm assuming FDA will then want controlled animal containment comparison vs. a leading brachytherapy device. If Radiogel deemed safer, we're good. If not, likely end of road for RDGL. Sad that all of this could have been done in 2021 had RDGL focused on the IDE application.