Vivos Inc (RDGL): Who said this is a solely time based ext...

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Re: rogers711 post# 178181

Thursday, 08/01/2024 4:01:58 PM

Thursday, August 01, 2024 4:01:58 PM

Who said this is a solely time based extension? Plain and simple fact is FDA ran out of time to complete the full review within the 30 day statutory requirement. FDA could have denied the application outright before acknowledging they ran out of time. They didn’t. FDA said, if you choose, you can resubmit the application for another 30 day review. In addition, here is a 45 day period to make some refinements. Vivos said yes, they would like to take the offer, refine the application then resubmit. Vivos would be negligent to not take the offer. This is much better for Vivos getting IDE approval.

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