Your argument misrepresents both the regulatory path for devices like RadioGel and the nature of the FDA process. RadioGel is regulated as a device, not a drug, which changes the trial requirements significantly. A double-blind comparative study isn’t the default requirement for devices with clear mechanisms of action and localized application, especially in cases involving unresectable solid tumors. The FDA often focuses on safety, dosimetry, and tumor targeting capability — all of which RadioGel is actively demonstrating.
As for MK “inviting” comparative studies: that’s a gross mischaracterization. What he has consistently focused on is safety and precision delivery, not superiority claims. The purpose of the IDE and upcoming studies is to validate that the gel effectively delivers yttrium-90 to targeted tissues without systemic leakage — something prior research and internal studies have already shown.
On the topic of patents: yes, the foundational work started at Battelle, and like most innovations, the tech has evolved. What matters now are the new patents and trade secrets surrounding the formulation, delivery mechanism, and clinical application — particularly the polymer matrix innovations introduced after 2020. Saying “anyone can make an offset” oversimplifies the complexity of bringing a radiological medical device through the FDA and NRC channels.
Finally, dismissing MK’s efforts as incompetent ignores the reality: very few individuals could resurrect a government-lab-born technology, create new IP, get NRC licensing, secure FDA pre-sub meetings, and open human trial pathways in a field dominated by big pharma and slow-moving academia.
Let’s stick to facts, not personal attacks. If you believe there’s no path forward for RadioGel, make your case without the spin.
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