Vivos Inc (RDGL)

[SC8]

Again, even if I stipulated to that (which I don't), that only applies to phase 1 containment tests. Phase 2 was efficacy tests, and those results have neither been mentioned or submitted to FDA. In any case, given MK slow walking this, it is doubtful all reviewers that approved the rabbit test plan are still on this case, and if so, your point is moot even for phase 1. If MK wishes to have the full benefit of presubmission discussions with FDA to increase odds of IDE approval, he needs to submit results in a timely fashion.