S2 E5.1 After the FDA Webcast: Beginning and Ending Perceptions

S2 E5.1 After the FDA Webcast: Beginning and Ending Perceptions

The Surfers and guests Manal Abdelmalek, Naim Alkhouri, and Akero Therapeutics Chief Development Officer Kitty Yale share high-level perspectives on the FDA Webcast, both before and after the group's detailed conversation

The panel shared overall impressions and key takeaways from the FDA webcast on NASH Drug Development, both before and after the detailed discussion. Key issues included the agency’s continued reliance on histology coupled with a willingness to accept digital pathology results, the importance of risk: benefit ratio in drug evaluation, the importance of a composite fibrosis+steatosis endpoint, and new approaches to clinical trials for cirrhosis.

How useful was this post?

Click on a star to rate it!

Average rating / 5. Vote count:

No votes so far! Be the first to rate this post.

Request A Transcript of This Episode
Request Transcript

Join The Discussion…

Ask Our Panelists A Question…

Podcast Quesitonaire
Is your question directed towards one of our panelists?

If your question is answered in our next Podcast, would you like be tagged?

Join The Discussion!

Subscribe to our free emails. Receive access to our Discussion Group. Ask your questions directly to our "Surfers"