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Post# of 817895
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Investor082

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Investor082

Re: manibiotech post# 805400

Tuesday, 12/30/2025 5:52:57 AM

Tuesday, December 30, 2025 5:52:57 AM

Post# of 817895
Correct. They are planning compassionate use in the US rather than regulatory filing/approval in the US. Also, they are spending money to pivot towards Direct and in licensed Roswell tech rather than L application in the US. Tells you everything you need to know.

Either way, no serious company would wait 5+ years since data lock to file in the biggest and most lucrative market. It’s crystal clear - they know FDA will reject so they continue to kick the can! Shorts have been correct about US FDA all along.
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