Can't blame FDA for not doing something that RDGL hasn't yet asked for. RDGL hasn't yet submitted an IDE application. Also, it's not FDA's fault RDGL changed their polymer process and now has to repeat all the prior bio-compatibility studies for IDE application, etc. Then there's the name dropping JHU regarding Radiogel. JHU vet clinic uses Isopet. JHU has no announced involvement in IDE application. RDGL has never mentioned any plans to conduct human trials at JHU.
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