You’re building a narrative around what isn’t public while ignoring how regulated medical development actually works.
First, abstract vs. full paper:
Regulatory animal studies are not published on the sponsor’s timetable. When data is being used in an active regulatory pathway, institutions routinely delay full publication until FDA review cycles conclude. That’s standard practice, not “peculiar,” and it happens across biotech—especially for first-in-class devices.
Second, “junk science” vs FDA reality:
If the work were “junk,” the FDA wouldn’t issue detailed deficiency letters, request additional characterization, or continue engagement. They would issue a Not Approvable and close the file. That hasn’t happened. Iteration ? rejection of the science; it means the bar is high and still being cleared.
Third, your claim that this is an “OTC circus” ignores one key fact:
Nothing about FDA review changes because a company trades OTC. FDA doesn’t care about message boards, PR tone, or share price. They care about containment, dosimetry, manufacturing control, and reproducibility. That’s exactly where the work has been focused.
Fourth, on the “rotation” trope:
Questioning timelines and asking for rigor is fair. Pretending that every delay equals fraud is not analysis—it’s cynicism filling in gaps where patience is required.
You keep saying “the FDA knows it doesn’t work.” If that were true, this conversation would’ve ended years ago.
The reality is simpler and far less dramatic:
This is a novel device navigating a hard regulatory path. That’s uncomfortable, slow, and boring—but it’s how real medical products are built.
Still swinging and still missing!
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