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PDUFA Date and Launch If the BLA is filed Q1 2027, expect FDA action around Q3 2027 (priority review) to Q1Q2 2028 (standard review), with commercial launch following 13 months later for manufacturing and distribution setup realistically late 2027 to mid-2028
Products like simethicone or activated charcoal may provide short-term relief, especially during the adjustment phase
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