Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings (:36), agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans (20:52), and Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide getting reviewed (32:23). More On These Topics From The Pink Sheet Adcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur: https://pink.citeline.com/PS150077/Adcomm-Open-Public-Hearings-Have-Become-Too-SponsorDriven--US-FDAs-Pazdur Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations: https://pink.citeline.com/PS150081/Clinical-Trial-Diversity-Requires-Sponsors-Work-With-An-Assortment-Of-Patient-Advocates-Community-Organizations Stealth’s Elamipretide Gets US FDA Review, But Same Questions Linger: https://pink.citeline.com/PS150070/Stealths-Elamipretide-Gets-US-FDA-Review-But-Same-Questions-Linger

Ask this episode

“What did the council decide on item 42?” — answered with the speaker and the moment.

Transcript

Related