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S2 E4 – What to Listen For Friday at the FDA Webcast

Manal Abdelmalek joins the Surfers to share expectations in advance of Friday's FDA Webcast on NASH Drug Development

FDA’s Friday webcast titled “Regulatory Perspectives for Development of Drugs for Treatment of NASH” is the agency’s long-awaited public event to provide better definition on what trial must achieve for a NASH drug to gain approval. In advance of that event, Stephen, Louise, Manal and Roger share expectations for that session. Kitty Yale, Chief Development Officer for Akero Therapeutics and a participant in our post-session podcast, sends in four points to explore. Whether you care about the process of drug development or simply the results in terms of drug approvals, you will find this episode a thought-provoking prequel to the actual event.

[PDF] FDA current thinking on NASH studies 2021

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