Again, you’re repeating the same tired argument that lacks both nuance and understanding of current FDA strategy, global regulatory positioning, and the actual value of RadioGel.
1. Patent Protection Myth:
Yes, the original patents expired, but you ignore the current IP portfolio, which includes new patents filed since 2022 tied specifically to RadioGel's next-gen formulation, new delivery devices, and novel production methods. IP evolves with the product. Investors aren't looking at expired filings—they're looking at the current, enforceable protection, which exists and has been extended.
2. First-to-Market Edge:
You claim Radiogel faces a "generic" risk. Where are the generics? Where are these so-called "offsets"? Nowhere. Even BetaGlue is years behind, and they don’t have an IDE with the FDA or real U.S. partnerships. The reality: nobody else has RadioGel’s radiological, immunological, and targeted profile, and certainly not with a scalable hydrogel platform cleared by the NRC for use with Y-90.
3. Buyout Value Isn't Just IP:
Buyouts today are driven by platform potential, clinical progress, and regulatory access. Telix didn’t partner just because of patents—they partnered because of what RadioGel is uniquely capable of doing. If Radiogel proves efficacy in humans—and it's nearing that step—it represents a new class of treatment. You want to talk low margin? Ask Telix what they think about treating inoperable tumors with precision isotopic therapy. It’s a premium segment, not a generic one.
4. India Strategy Misrepresented:
Claiming MK “just figured out” India is needed is willfully false. India is being used strategically to fast-track human trial data in a compliant, cost-effective way while the FDA IDE process finalizes. It's not an oversight—it’s part of a dual-track global approval strategy. India has hosted successful trials for major pharma firms including GSK, Novartis, and Pfizer. The FDA does not automatically reject Indian trial data—it requires proper alignment, which Vivos is executing with expert regulatory guidance.
5. MK’s Timeline and Deliverables:
Let’s get the timeline straight. The FDA didn't even have a clear path for radiopharmaceutical devices like this until recent years. Since 2021, MK and his team have:
Resolved NRC classification,
Partnered with Mayo Clinic and Telix,
Finalized cGMP production,
Conducted IND-enabling studies,
Submitted an IDE now under final FDA evaluation.
That's actual traction—something no competitor has achieved in parallel.
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Bottom line: Your post shows a biased misunderstanding of how biotech valuation works. You're not here to inform, you're here to distort. And it’s not working. Investors are watching the IDE decision closely because we’re on the cusp of the first human trials—an inflection point no "moron" could have reached without serious strategic execution.
#RDGL
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