Vivos Inc (RDGL)

[kayak_wench]

This is ridiculous. Typically companies don’t have to do any genotoxicity texts. But if you research it when they do the tests those tests take a few weeks to a month. Here we are at a multi-phase test suite that is dragging out for many months. This came up last spring. It took several months for the fda to communicate what they wanted, we do it, and as usual they want more. It is becoming obvious the testing is never ending. Maybe giving us BDD was a way to slow us down more. Maybe it came with new reviewers and we will have to repeat everything a 3rd or 4th time. The next thing we will hear is that 10 more rabbits have to die to keep FDA reviewers entertained.

I didn’t think the FDA would jerk us around forever because it would make other companies think these special review programs are a waste of money. Problem with that thinking is that the FDA has all the power. It doesn’t matter what small companies think. If the FDA tells a small company to jump it has to jump. Problem is large companies give cushy jobs to ex-FDA employees. So large companies are the ones telling the FDA to jump.