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Saturday, January 31, 2026 9:19:34 PM
Nothing you’ve said is “verifiable” in the way you’re implying — it’s interpretation layered on assumption.
In early first-in-human work, “useful” is a precise, cautious medical term, not a euphemism. Physicians do not declare devices “revolutionary” after a single early case — that language comes years later, after durability, safety, and reproducibility are established. Anything else would be irresponsible and non-compliant.
As for the “80%” fixation:
Partial response is a defined oncology endpoint. Chemo, immunotherapy, and radiation routinely report partial responses well below 100% and still advance. Expecting complete eradication from a first-in-human localized therapy reflects a misunderstanding of oncology practice, not a defect in the device.
Remission rate after one patient?
That question doesn’t even make sense at this stage. Remission is a population-level, longitudinal endpoint, not something responsibly claimed from a single early case — especially at 8 months.
You’re criticizing the team for not doing what would actually get them in trouble:
over-claiming, extrapolating prematurely, or marketing before data maturity.
Cautious language in early human use isn’t a red flag — it’s exactly what competent clinicians and regulators expect.
If this were “junk,” the language would be louder, not quieter.
Another whiff!
In early first-in-human work, “useful” is a precise, cautious medical term, not a euphemism. Physicians do not declare devices “revolutionary” after a single early case — that language comes years later, after durability, safety, and reproducibility are established. Anything else would be irresponsible and non-compliant.
As for the “80%” fixation:
Partial response is a defined oncology endpoint. Chemo, immunotherapy, and radiation routinely report partial responses well below 100% and still advance. Expecting complete eradication from a first-in-human localized therapy reflects a misunderstanding of oncology practice, not a defect in the device.
Remission rate after one patient?
That question doesn’t even make sense at this stage. Remission is a population-level, longitudinal endpoint, not something responsibly claimed from a single early case — especially at 8 months.
You’re criticizing the team for not doing what would actually get them in trouble:
over-claiming, extrapolating prematurely, or marketing before data maturity.
Cautious language in early human use isn’t a red flag — it’s exactly what competent clinicians and regulators expect.
If this were “junk,” the language would be louder, not quieter.
Another whiff!
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