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Re: SC8 post# 197146

Wednesday, 02/18/2026 8:06:09 AM

Wednesday, February 18, 2026 8:06:09 AM

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That’s not a “lie.” It’s standard industry terminology.

“Clinical-stage” means a company is pursuing or preparing for human clinical trials — not that an active Phase III trial is currently enrolling.

Plenty of biotech and device companies are described as “clinical-stage” while:

• completing preclinical requirements
• preparing IDE submissions
• awaiting regulatory clearance
• engaging in pre-sub meetings

Clinical-stage does not mean “currently enrolling patients this week.”

If FDA believed the company was fraudulently misrepresenting status, that language would trigger immediate regulatory scrutiny.

It hasn’t.

Calling standard classification terminology a “lie” just shows you’re stretching for outrage.

Pity the fool listens to your lies
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