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Peterson, G., Bai, J., Nagaraja, T

Quality Assurance Standards Each production lot is subjected to rigorous analytical evaluation to meet pharmaceutical-grade specifications

What they found: Favorable safety profile , no serious adverse events at doses up to 100 g/kg Preliminary efficacy signals positive The program stopped before Phase 3 for unknown commercial reasons (the program passed through several sponsor rotations and no one ultimately carried it through) Why it matters: These are the only published clinical data in humans that we have

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APC emphasizes the need for more comprehensive information about the FDA's substance-specific safety concerns

A COA that lists benzyl alcohol as "present" without a quantitative result is incomplete presence is not the question