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Those patients receiving the combination SEL-212 product received sequential IV administrations of ImmTOR immediately followed by pegadricase, with the exception of the cohort of patients that received 0.4 mg/kg pegadricase followed 48 h later by an IV infusion of 0.03 mg/kg ImmTOR

To get a drug FDA approved, a company must conduct phase 1, 2 and 3 clinical trials proving safety and efficacy of the compound through a laborious, multi year and extremely costly process

Diabetologia 58:799808

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