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Why the Vote Was Close: FDA's Stated Concerns FDA's briefing material for the meeting is the clearest public statement of why TB-500 has never advanced, and it maps directly onto the questions researchers ask most often: FDA concern What the record shows No human safety studies FDA's review identified no human safety studies for TB-500 — zero drug-exposed participants, no pharmacokinetic data, and no immunogenicity or aggregation assessment

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X-rays sometimes show the calcifications in the joints, in tendons, or in soft tissue near the joint