Vivos Inc (RDGL)

[kayak_wench]

IDE submission will be in January and approval in February 2024!
At least that is what I believe. From our price it is evident most investors are unaware of how close we are to having Radiogel approved as an IDE (approval will within 30 days of submission). That will be a milestone that will fundamentally change the nature of this investment. They either refuse to believe what Korenko is telling us because of constant detractors and the fact the OTC is riddled with companies that exist solely to make a buck off of pretending to have potential. I am talking like an IDE is a slam dunk because the company has worked closely and done everything that the FDA asked them to do and even repeated tests on their own discretion to cover all the bases. The FDA cannot afford to turn around and deny a company that agrees to work with them under their program designed to ensure that everything is in order prior to submission.

Here is a progression of the IDE application development in 2023. It has been a very long year where our hopes were dashed early on and where we had to endure several months having no idea how much or how long the extra testing would go on. But as shown through the references made over the year as to the timeframe of submission it is very close at hand. I think we are so close that it is possible the PR for the IDE submission comes out at the same time as the end of the quarter summary.

In early Feb 2023 he told us

We submitted the revised IDE to the FDA and asked to schedule another pre-submission meeting.

In the late Feb 2023 blog we learned that

After the animal study is completed the final draft of the IDE will be submitted.

The early Apr blog didn't have any reference to the IDE while the early May blogs just said they would be continually revising the IDE to improve it. Then the early July dropped the genotoxicity bomb and again didn't mention anything about when the final IDE would be submitted. Continued silence until the early Sept Q&A where, in response to a question about when the IDE would be submitted Korenko told us they just don't know.

Our specific plan for the next IDE submission depends on the results of the feedback from the FDA at the next meeting scheduled for September 29, 2023.

Finally we see the light at the end of the tunnel in the Oct update

Our next IDE application will be an amendment to the previous submittal. We are systematically preparing the answers to the 60 previous FDA comments. And as we near completion ..... .

The Dec 20 BDD PR has the first indication that Korenko believe's the IDE development is over and we have a submission date planned when he uses the

....our upcoming IDE submission...

Now just a few days later, with a tweet on Dec 28 that has no purpose other than to let us know how darn close we are to submission Korenko lets us know the IDE is coming fast with the phrase

As we approach certain milestones ....