Intercept CRL Likely About OCA-Specific Concerns, Not NASH Endpoints
Executive Summary
The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.
You may also be interested in...
NASH Drug Development Questions? US FDA Has Many Of The Answers
From biomarkers to treatment effect size, agency officials respond to some of more than a hundred questions that poured in during a webinar on development of drugs to treat the liver disease.
A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions
As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.
US FDA Picks Up The Pace Of Complete Response Letters Over June And July
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.