RedHill Biopharma Ltd.
RHB-204
Crohn's disease
Date
TBD
FDA decision · Date TBD estimated
What's at stake
An FDA complete response letter on RHB-204 for Crohn's disease is in focus around Date TBD.
Primary source
· SEC 6-K
verified 15h ago
“Based on the FDA guidance on path to approval, RedHill’s novel Phase 2 RHB-204 study is designed to be the first-ever adequately controlled clinical study in a specifically defined MAP-positive CD patient population - a potentially paradigm”