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Post# of 177475
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Friday, 12/22/2023 12:27:05 AM

Friday, December 22, 2023 12:27:05 AM

Post# of 177475
Reading this again and it certainly sounds as if they submitted the Genotoxicty report amoung others this current quarter to have the press release read as it does
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The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness.


They also say this IDE submission is asking for approval for human trials which after this news I cannot see that denied . I'm wondering if they submit the mayo protocol with the application or they will do that after approval
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