Vivos Inc (RDGL)

[wrinklesobw]

They didn’t meet all the criteria for the BDD the first time.

Also Radiogel is in the EFS IDE process.

In short it takes a longer going this route because we are essentially given a set of board members(7 or 8 personnel) from the fda to review the data, and questions from the Radiogels team. By going this route alone increases the ide approval to 75 percent.

Problem going this route the board can ask for new data/tests at anytime. A good/bad route but with every additional request it’s less of a chance for denial.

Also there are John’s Hopkins and Mayo Clinic’s doctors that sit on the meetings with Doctor Korenko with Radiogel.

To prolong things, they changed the formula enough to be able to get away from leasing fees from Battale. By doing this some tests have been requested to be done again.