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PDUFA Date and Launch If the NDA is filed Q4 2026, expect FDA action around late 2027 (priority review) or Q1 2028 (standard review), with commercial launch following 13 months later for manufacturing and distribution setup

In some cases, patients may be transitioned to an alternative medication that is safe for pregnancy and can be used to help manage their metabolic health during pregnancy

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Agency feedback can mean more data collection or further analysis, which can shift this timeline

A serve of nuts is 30g, or a handful