COBALT study in advanced PBC, previously terminated early due to feasibility challenges, did not demonstrate a statistically significant difference in clinical endpoints between Ocaliva® and placebo
HEROES-US real-world analysis demonstrated statistically significant improvement in event-free survival in patients receiving Ocaliva for PBC
Intercept plans to include these data in an evidence package that will be submitted to U.S. FDA in 2H 2022 to support post-marketing regulatory requirements
https://finance.yahoo.com/news/intercept-announces-clinical-trial-real-113000483.html
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