Expert Committee Clears Ravenbhel to Begin Resmetirom Phase 3 Trial, Asks for BE Data First
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New Delhi: The Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organisation (CDSCO) has permitted Ravenbhel Biotech to proceed with a Phase III clinical trial of its Resmetirom Tablets 60 mg, 80 mg, and 100 mg, contingent upon submission of a Bioequivalence (BE) study report.
The firm presented a revised Phase III clinical trial protocol before the committee during the SEC meeting held on 25th June 2025, in continuation of an earlier SEC recommendation dated 17th March 2025.
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