Vivos Inc (RDGL)

[SC8]

Again, it's not FDA's fault MK takes years to respond to their comments and suggestions, by which time both the state of brachytherapy art and FDA reviewers have changed, requiring MK to almost start over again with FDA. As with anything in business and life, when dealing with FDA, time is always of the essence, aka time kills all deals.

Add to MK never showing any urgency in regard to the above, he has repeatedly and wrongly blamed FDA reviewers for delays, such that reviewer turnover shouldn't surprise anyone. Likewise, he often makes completely unsubstantiated product attribute and comparative safety claims that must leave FDA reviewers scratching their heads in disbelieve that MK is serious about getting Radiogel to human trials.

All delays to date have been 100% due to MK's ineptitude.