You keep confusing regulatory process with final approval — deliberately.
BDD doesn’t guarantee IDE approval, but it does mean FDA saw enough novelty and potential benefit to prioritize review. IDEs get declined, revised, and resubmitted all the time — that’s normal device regulation, not “snake oil.”
Animal studies, genotox work, and papers aren’t “distractions”; they’re literally what FDA requires before authorizing human trials. Lack of public publication doesn’t = lack of submission to FDA — regulators review data long before journals ever see it.
Repeating “26 years” and “rejected twice” doesn’t turn an ongoing regulatory process into fraud — it just signals you don’t understand how medical devices actually move forward.
Same FUD, same talking points, different day.
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