Let’s separate your deranged emotion from reality for a second.
Preparing manufacturing capability before IDE approval is not “criminal.” It’s standard biotech protocol.
If you wait until after IDE clearance to:
• secure a production site
• validate equipment
• submit radiation handling licenses
• establish GMP protocols
—you delay first patient dosing by 6–12 months minimum.
Regulators expect readiness.
Manufacturing planning doesn’t = commercial production. It means being prepared if authorization is granted.
That’s called operational sequencing — not “cart before the horse.”
__________
Second:
No one is “putting Radiogel into human bodies without FDA approval.” IDE approval is required before U.S. trials begin. That is publicly acknowledged.
Preparing infrastructure while regulatory review proceeds is risk management — not fraud.
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Third:
Calling something “criminal per SEC standards” doesn’t make it so. If there were securities fraud:
• There would be an SEC investigation
• There would be enforcement action
• There would be trading suspension
None of that exists.
Throwing around legal accusations without evidence is reckless — not insightful.
__________
Finally:
If management truly believed the product had no path forward, they wouldn’t be investing in:
• facility readiness
• process scaling
• regulatory compliance buildout
Scams avoid capital expenditure.
They don’t prepare manufacturing pipelines.
You can disagree with timing.
You can dislike dilution history.
You can question strategy.
But calling standard biotech preparation “criminal” just exposes how little you understand how regulated medical manufacturing actually works.
When outrage replaces analysis, the argument’s already lost. And you’ve lost. Another swing and a miss!
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