In this conversation, Professor Manal Abdelmalek joins the Surfers to explore some of the specific items for which they hope the FDA will provide clear guidance at its January 29 webcast on NASH Drug Development. Key issues included: (a) how to manage sample sizes with both safety issues and the need for patient heterogeneity in mind, and (b) whether we can seek to reduce screen fail rates by utilizing high-value non-invasive tests like MR elastography and MRI-PDFF in qualifying patients for clinical trials.
