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AOD9604 displayed a very good safety and tolerability profile indistinguishable from placebo

This deficiency can lead to megaloblastic anemia, where the body produces large, abnormal red blood cells that cannot function effectively, resulting in symptoms such as fatigue, weakness, and neurological issues

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The company states that no insurance billing is involved, and that HSA and FSA payments are accepted

Adcoms for biosimilar applications are not always required, but when the agency schedules one, the adcom outcome is a strong predictor of approval timing and any conditions the agency might attach to approval