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Current limitations include the complexity of the mechanisms of action, which makes it difficult to identify predictive biomarkers of response, the lack of detailed pharmacokinetic data for synthetic TB-500, and the difficulty of translating effective doses from animal models to humans

FDAs introductory briefing document states that the agency does not intend to issue a final determination until it has considered input from the advisory committee process and finalized its reviews

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Both scenarios are valid depending on the underlying health context