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Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement

The main findings in rabbits were flexed, rigid flexor or medially rotated forelimbs or hindlimbs and domed heads at external examination

These results validate that the AR-AST System achieves quantitative bacterial counting across a 6-log dynamic range (10 to 10 CFU/mL), with high accuracy (Log deviation 0.05).The low-noise, high-sensitivity detection characteristics of the system ensure reliable comparison of different drug combination effects, allowing observed synergistic/antagonistic interactions to be attributed to true pharmacological interactions rather than experimental variability

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The positive votes came despite highly critical reviews from FDA staff scientists, who said there was little data that BPC-157, TB-500 and the other chemicals can be safely used for medical purposes