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S2 E4.1 – Anticipating the FDA Webcast: Overall Areas for Guidance

Manal Abdelmalek joins the Surfers to discuss key themes they hope to hear at the January 29 FDA Webcast on NASH Drug Development

In this conversation, Professor Manal Abdelmalek joins the Surfers to explore some of the major themes they hope the FDA will address at its January 29 webcast on NASH Drug Development. Key issues included: implications of safety: efficacy tradeoffs in the approval process, expanding use of non-invasive testing during Phase 2 trials, and language in the agency’s white paper suggesting that Phase 3 trials possibly should be two years or longer.

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