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?