September 06, 2023
RadioGel™ - FDA IDE Progress Update
We've received numerous emails regarding where we are on our timeline in regards to our FDA IDE submission progress with RadioGel™ .
We have chosen to respond to the main inquiries in a question-and-answer format, which will allow us to disseminate the information to our entire shareholder base, and not one particular shareholder or potential investor. Please note that we will not respond individually to any email that requests confidential information that has not been properly vetted and disclosed to the public.
Retail investor questions and answers:
When is the next FDA meeting or has Vivos already had it?
The next FDA Pre-Sub meeting is scheduled for Friday, September 29, 2023.
What is the status of the genotoxicity proposal - is it ready?
Per the FDA recommendation, the proposed Genotoxicity Chemical Characterization Protocol was sent to the FDA for their comments on 7/23/23. Unfortunately, it has taken this long to get on their schedule.
The FDA will give us written comments about a week before the meeting, which provides the basis for discussion.
Are you planning on submitting the IDE after the genotoxicity (proposal/testing/protocol) testing is finished, or are you staying on the same path?
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.
Collectively we decided that our approach would be to submit an amendment to the previous IDE. Listing and then addressing all the FDA comments over the last five years, and then providing the answers - sometimes for the second time. This allows us to build on our progress and is the optimum way to communicate since 50% of the FDA reviewers are new.
Thank you for your continued support.
Mike Korenko, Sc. D
CEO & President Vivos Inc.
