FDA Q&A SESSION: On the Edge of Market Approval
Date & Time
Thursday, June 4, 2020, 11:10 AM - 11:40 AM
Qun Wang Nikole Kimes

With Rebiotix’s positive initial phase 3 clinical results, this is the perfect opportunity to ask the FDA direct questions regarding the future of microbiome-based therapies and the route to market approval:

• With multiple modalities being used to modulate the gut microbiota, what biomarkers do you needed to be measured to determine PK and PD?

• How do we measure the safety and efficacy of microbiome modulating drugs?

• What will be required from the FDA in terms of standardisation of these measurement methods? How will Rebiotix’s positive phase 3 results impact this?

Session Type
Virtual Session Link
Session Themes
Regulatory Challenges
On Demand