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FDA Concerns About Baraclude Cancer Risk Tempered By Hepatitis B Virus Oncogenicity

This article was originally published in The Pink Sheet Daily

Executive Summary

After Carcinogenicity Assessment Committee establishes a potential risk in humans, Bristol proposes 12,500-patient, long-term, postmarketing safety study. Implications and design of the study are a primary focus of reviewers' discussion of hepatitis B agent's safety.
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