That's what happens when one like MK asks FDA for suggestions for a strong IDE application and then resists and foot drags against those suggestions. So years go by, and when he finally gets back to FDA, he has to face new reviewers or previous reviewers in the course of time have other view points now. In this case, he has yet to submit the rabbit data that FDA suggested back in 2021 and the genotoxicity omission was flagged in a 2nd draft IDE review that MK submitted well over a year after getting FDA comments on his first draft. Both the controlled animal studies and the genotoxicity issue would have already been addressed years ago by competent management anyway.
Regarding patents, except for trademark, Radiogel is public domain now. RDGL has a process patent of little value and has applied for some device improvement patents. That combined with whatever expertise MK has are all moot if RDGL can't be bothered to get Radiogel FDA approved. To date, RDGL has proven incapable of even getting Radiogel to human trials.
Face it, MK has proven an inept gross incompetent mired in hopeless IsoPet business at expense of only thing that matters now. Fan boys just keep moving the goal posts and apologizing for inexcusable f-up after f-up. Yeah, sometimes a blind squirrel finds some nuts, but most blind squirrels starve to death. MK needs to go.
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