Vivos Inc (RDGL)

[kayak_wench]

I think we could see actual IDE submission as early as end of May.

Where RDGL is right now in terms of IDE submission (and a little history for new investors).
- Mayo clinic has partnered with RDGL to facilitate getting IDE status approved so they can use it on their patients.

- Following a failure to be given a Breakthrough device (BDD) in Dec 2021 RDGL started a Q submission path to be granted an IDE. It is basically the same program as the BDD but on a slower clock. The first meeting to kick off the Q submission process was in May 2022. At that meeting the FDA, RDGL and Mayo clinic doctors agreed on what they called a "clear path forward with the review team toward obtaining the IDE needed for the first in human clinical trials". The most important of which was additional animal testing to validate Radiogel does not migrate.

- RDGL worked with John Hopkins University Veterinarian clinic to develop and perform an animal testing procedure to address FDA concerns. The tests involve growing VX-2 tumors in rabbits, treating them with radiogel then following up with PET imaging to validate Radiogel does not migrate. Getting John Hopkins to do the testing was vital as growing VX-2 tumors is very difficult and having a medical facility that is used to research and testing ensures proper procedure is followed.

- John Hopkins Vet is actively using radiogel in its for profit vet clinic (https://www.hopkinsmedicine.org/news/articles/radiopharmaceutical-therapy-in-veterinary-patients).

- The FDA reviewed and approved the animal test plan. Meaning if the test is successful no additional animal studies are needed.

- Rabbit testing was initiated sometime in Feb.

- A second draft of the IDE was also submitted sometime in Feb. This draft contained all the additional testing and information the has FDA requested except the results of the VX-2/rabbit study. RDGL expects the results of the review of this second draft back in early April.

- Mayo clinic doctors believe IDE is so close Mayo clinic has scheduled a surrogate tissue training exercise in April.

Tomorrow we should get clear insight into how the rabbit test is proceeding and hopefully, if it is not already done, when it will be completed.

I expect it will take John Hopkins no more than a couple of weeks to write up the results of the rabbit study (I reviewed the instructions for writing up such a plan and much of it is documented/written as the test proceeds). The review of second draft IDE is expected to take a month to 6 weeks. So it is safe to assume the review of the third and final draft IDE will take no more time.

What I see as the best case scenario on possible schedule for IDE submission
- FDA second review of IDE finds no issues and reports that by the end of the first week of April. At that time the animal study has already been completed and its report written up.
- RDGL submits final draft of IDE to FDA by mid-April.
- FDA responds back to RDGL by end of May that the draft IDE is good.
- RDGL submits actual IDE late May to early June.