Replies to post #169759 on Vivos Inc (RDGL)

[den4]

I don’t know.. Why did they submit an 8-K at the last update?

[mc73]

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.

[Cameron12221]

If I had to take a guess, the FDA reused the original submission. The only reason why they were denied was due to lack of historical data or whatever. Basically lack of recognized testing. That was taken care of with the EFS program.


The EFS program could of also lead them into the BDD. Again these are complete guesses.

[mc73]

My bad...you are reaching back for news on BDD. Here is the press release from Jan 19, 2021.

https://www.globenewswire.com/en/news-release/2021/01/19/2160754/0/en/Vivos-Inc-Receives-Feedback-from-FDA-on-Breakthrough-Designation-Request.html