The panel discussed key takeaways from the FDA webcast on NASH Drug Development on the subject of endpoints. The group focused discussion on a few issues: (a) histology, both in terms of its continued primacy as a surrogate for pre-cirrhotics and FDA’s willingness to accept digital histology; (b) ratification that “the goal posts” are not moving on the endpoint issue; (c) frank statement that risk:benefit ratio will shape how the agency evaluates drug candidates; and (d) histopath adjudication.
