Vivos Inc (RDGL)

[wrinklesobw]

I find it funny that there’s still a couple aaaaa on here that think isopet is to blame for so called mistakes and the reason it’s taken so long to get this far.

Fact the doctor took the EFS IDE path which was suggested by the FDA

Fact The doctor said at the beginning that this path will take a lot longer and will cost significantly more to go this route because the FDA has open communication with the company and will make suggestions as to what tests will need to be done during this process.

Fact The FDA did NOT suggest all of the testing that needed to be done at the beginning FACT is the FDA suggested a different type of test at just about every meeting that was held.

Fact all testing was done by a third party, which means that they more than likely did not start said tests as soon as the company found out about said testing that needed to be done.

Fact after each FDA meeting where the FDA suggested a test, the company had to write up-methods of procedures and write in the protocols suggested by the FDA then have another meeting with the FDA to approve them.

Fact after the second meeting the FDA swapped out 8 doctors that knew nothing about radiogel, which when this happened the new FDA doctors suggested to redoing some of the tests already done.

Fact ISOPET is 100 percent approved through the FDA to be used on dogs, cats, horses and all other animals, as well all 18 indications can be used on animals to continuously collect data from each patient.

These aaaaaa which are aaaaa would be the only ones to think that delays were because of isopet and the doctor