Roger Green discusses why despite widespread concerns, FDA's Complete Response Letter to Intercept did not cripple progress in NASH drug development.
Observers feared that after Intercept received its CRL, investment into NASH drug development would dry up and knowledge would slow. Instead, Roger Green describes how drugs that had reached Phase 2 development maintained sufficient momentum to move forward. As a result, therapeutic focus shifted from treating fibrosis in late stage patients (obeticholic acid's benefit) to treating the whole patient, including not only NASH but the full range of metabolic considerations. Net result: the vibrant, "boiling hot" market for NASH clnical trials and researchers that Vlad Ratziu described and the prospects that several exciting classes of NASH drugs will be here soon.