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Gut colonization by oral bacteria, especially Klebsiella species, had been responsible for a T-helper 1 (TH1) cell induction and inflammation in genetically susceptible host [46]

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As BioSpace reported, in February, Vinay Prasad, former director of the Center for Biologics Research and Evaluation, refused to file the application, but the agency's briefing documents published earlier this week suggest a more favorable view of the submission