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S2 E5.2 – After the FDA Webcast: Discussing Clinical Endpoints

The Surfers and guests Manal Abdelmalek, Naim Alkhouri and Akero Therapeutics Chief Development Officer Kitty Yale discuss sections of theFDA Webcast that centered on clinical and surrogate endpoints

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.

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