Vivos Inc (RDGL): They haven't submitted the IDE. They hav...

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Re: wrinklesobw post# 169759

Tuesday, 01/16/2024 9:03:11 PM

Tuesday, January 16, 2024 9:03:11 PM

They haven't submitted the IDE. They have to schedule another meeting with the FDA 1st. I am hoping that the FDA will tell our CEO they have all the data they need and ask him to submit the IDE at their next meeting.

My guess (and hope!) is the next meeting with the FDA will happen sometime in March. Sometime later (I'm thinking within 30-60 days IDE is submitted. If my crystal ball is right (assumes no further delays to include all data from rabbit study and genotoxicity study are complete as of today and data is good), we should have IDE sometime in June.

Again, this assumes everything goes perfect from here till then. Unless and until there is a public notification and subsequent 8k filing of the IDE submission, I am a very concerned investor.

We will know SOON if there are further delays for cancer patients and shareholders.

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