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Thursday, July 25, 2019 10:09:43 AM
My understanding is that Brachytherapy is already FDA approved for cancer tumor treatment in humans as a device. As is Y90 and the tunable gel.
My understanding of the outcome of the last FDA submissions was that nonhuman use for all cancer tumor types currently has FDA approval and now a clinic is offering this treatment under a name dedicated to animal treatment to avoid confusion because human treatment is functionally the same device.
Previously, the FDA wanted to pursue human approval as a class 3 device (greater hazard level) whereas Dr. Korenko et al decided to pursue FDA approval as a class 2 device. The Y90 is less radiative than cesium 131 and there are no beads, peanuts, or darts left behind in the patient. This difference in opinion over submission triggered the "FDA 5" dog treatments as I call them. Data is recorded in a manner acceptable to FDA in an effort to resolve the class 2 vs class 3 medical device discussion. I think the last of the FDA 5 have been or soon will be treated with data submitted to FDA.
A vaccine is loosely characterized as injecting inert or "dead" versions of a virus cell into a human such that the immune system responds to eliminate that virus cell. One of the possible ancillary effects of an immune system confronted with necrotic cancer tumor tissue was always that an immune system response MIGHT be observed allowing the patients own immune system to fight off or reduce tumors of similar type to the treated tumor.
I am encouraged to hear of the recent patent submission and if approved I think a PR on the content will be PHENOMINAL.
I suspect there will be a PR on data submitted to FDA for approval as a class 2 medical device for skin cancer within the next 90 days. If approved, I would expect FDA approval for other cancer types to follow in relatively short order given RTT.
I can imagine a world where a breast cancer tumor diagnosis simply means a 12-21 day tumor destruction treatment that trains a woman's immune system to be more resistant to future tumors and / or renders metastatic cancer cells to be non issues as her immune system just cleans them up.
What would the PPS look like for a company capable of doing that, do you think?
-Go RDGL$$$$
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