Vivos Inc (RDGL): Again, FDA review in pre-submission disc...

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Vivos Inc (RDGL)

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Re: chereb19 post# 161427

Tuesday, 05/09/2023 3:43:18 PM

Tuesday, May 09, 2023 3:43:18 PM

Again, FDA review in pre-submission discussion program is a review of whatever RDGL has submitted with goal of FDA making helpful suggestions for a stronger IDE application down road. Until the IDE application is submitted, FDA is not reviewing the device for human trials.

RDGL's Twitter statement "Our (PRnT) device is currently undergoing review with the @US_FDA." is false.

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