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WALLnut

12/06/25 10:29 AM

#195452 RE: SC8 #195451

Again, you’re actually helping make the real case here.

IsoPet “being a decade old” doesn’t hurt the story — it strengthens it.
Most OTC biotech concepts never survive a single product cycle. IsoPet has:
• a decade of real-world tumor treatments,
• multiple clinics performing procedures,
• ongoing demand,
• repeat cases,
• and continuous interest from veterinarians who actually use it.

A product that supposedly has “no market” doesn’t last 10 years and expand into new clinics. That alone shows you’re ignoring the obvious.

As for “sold below cost,” that’s literally how almost every medical technology enters the field.
Early-stage devices — yes, early stage — build adoption first, revenue later.
Pacemakers, dental implants, radiation delivery tools, all followed the same trajectory. It’s called market seeding, not failure.

And your argument that FDA “ignores IsoPet data” is also off-base.
They don’t use IsoPet outcomes as a substitute for controlled studies — of course not.
But real-world animal responses, safety outcomes, and absence of migration absolutely inform FDA expectations, manufacturing updates, dosimetry planning, and risk assessments.
That’s why the Sprint program exists: to guide companies in building the exact dataset FDA wants.

IsoPet isn’t a distraction —
it’s Radiogel’s longest-running proof of concept.

The only “distraction” is pretending that a decade of safe clinical use somehow counts as zero.

As for volume, stability, or calling the company a scam — you’ve been predicting the same doom for years while the company keeps:
• refining the chemistry,
• filing patents,
• expanding IsoPet,
• engaging FDA,
• treating real tumors internationally,
• and moving step-by-step toward IDE clearance.

That’s not what scams do.
That’s what determined regulatory biology companies do.

But hey.... thanks for lining up the talking points that show why the long game is still very much alive.


$RDGL
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CatfishHunter

12/06/25 10:38 AM

#195453 RE: SC8 #195451

Still leaning hard on the “two decades” talking point, but that argument completely collapses once you separate technology age, regulatory process, and business model — which you keep mixing into one dramatic conclusion.

Let’s go through the parts you’re misrepresenting.
__________

1️⃣ “Two decades old” doesn’t mean “not early stage.”

A technology’s invention date has nothing to do with when it becomes commercially mature.

If invention date = maturity, then:
• mRNA vaccines (invented 1990s) weren’t “early stage” in 2019
• CAR-T therapy (discovered in 1980s) wasn’t “early stage” in 2015
• Proton therapy (concept from 1940s) wasn’t “early stage” in the 1990s
• CRISPR (discovered 1993) wasn’t “early stage” in 2018

All wrong.

Biotech is full of technologies that exist for years before a company has the money, people, or regulatory sophistication to move them forward.

Radiogel is “early stage” today because regulatory progress — not invention date — defines the stage.

You’re using a calendar instead of the industry’s actual timeline.
__________

2️⃣ “IsoPet was launched a decade ago” doesn’t mean it was launched into a real market

IsoPet was launched into one of the smallest medical markets possible:
• nuclear-licensed veterinary oncology
• requiring specialty clinics
• with limited adopters
• high handling overhead
• high regulatory burden
• no scale manufacturing

Zero early-stage radiotherapeutics make money in markets this small.

IsoPet was never the revenue engine.
IsoPet is the live-animal validation platform — the part that demonstrates:
• localization
• gelation
• confinement
• injectability
• decay behavior
• multi-species tolerability

You keep attacking IsoPet for not being what it was never designed to be.
__________

3️⃣ “Sells below cost = no market” is not how early-stage medical tech works

Every emerging radiotherapy platform sells below cost early on.

Because early sales are not about profit — they’re about:
• adoption
• accumulating case data
• clinician familiarity
• validating real-world performance
• manufacturing scale learning

If “sold below cost” meant “hopeless,” then literally every radiotherapy platform in history would be hopeless.
__________

4️⃣ “FDA ignores IsoPet cases” is a straw man

No one ever said IsoPet cases = FDA submission.

IsoPet provides supportive biological evidence of:
• particle confinement
• dose localization
• gel behavior in tissue
• decay kinetics
• lack of systemic migration
• clinical usability

The FDA still needs:
• structured, controlled data
• complete dosimetry modeling
• reproducible protocols
• a polished IDE

And that is exactly why Vivos restructured and brought in:
• Brad Weeks for operational leadership
• Dr. John J. Smith (Hogan Lovells) to rebuild the IDE package

You keep pretending that “IsoPet ? FDA submission” is some kind of revelation — it’s literally how the process works.
__________

5️⃣ “By all appearances RDGL is a scam” — still no evidence

A scam requires:
• fake tech
• fake data
• fake trials
• fake facilities
• fabricated results
• SEC findings
• regulatory warnings

Instead, Radiogel/IsoPet has:
• real nuclear manufacturing
• real Y-90 hydrogels
• real veterinary oncology use
• real physicists and oncologists involved
• real dosimetry models
• real FDA interactions
• real Breakthrough Device Designation

You keep accusing “scam” because it’s emotionally satisfying — not because you can cite a single document backing it up.
__________

6️⃣ Your entire argument reduces to one fallacy:

“If it’s slow, it’s dead.”

That’s not how medical device development works.
That’s not how radiotherapeutics work.
And that’s not how regulators work.

Radiogel’s problems have always been execution, and that’s the exact area the company finally fixed.
Your competitor’s problems are physics, and physics cannot be fixed.

Speed dos not = superiority.
Delay does not = death.
Frustration does not = fraud.
__________

Calling IsoPet and Radiogel “scams” without a single regulator, document, safety ruling, or scientific finding to support it isn’t analysis — it’s just you repeating your feelings louder.
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chereb19

12/07/25 4:31 PM

#195460 RE: SC8 #195451

😂👋😂👋 someone's angry today 😂👋😂👋

The doc is getting it done. That must hurt.