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Assuming Phase 3 results are positive and an NDA is filed, FDA review typically takes 6 to 12 months under standard review or 6 months under priority review designation

Informed decision-making involves understanding both the substantial evidence supporting safety and efficacy, and the importance of ongoing monitoring

(i) A task-structured synthesis (classification, extraction, normalisation, pipelines, resources, analyses) with comparative model effectiveness across families and benchmarks

This has led to serious infections in some cases, including bloodstream infections and abscesses