Vivos Inc (RDGL): Yes, if MK submits IDE application with...

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Re: chereb19 post# 172191

Tuesday, 04/02/2024 12:50:28 PM

Tuesday, April 02, 2024 12:50:28 PM

Yes, if MK submits IDE application with major uncompleted items like he's revealed so far, best one can hope for is a conditional approval.

No way is FDA going to green light human trials with product that isn't made to their standards or administered by untrained physicians. Those items would have to be resolved to FDA satisfaction beforehand, aka a conditional approval.

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