Summit Therapeutics said it received feedback from the Food and Drug Administration that the FDA does not agree with the change to the primary endpoint that Summit proposed and has subsequently implemented in its ongoing Phase III Ri-CoDIFy studies when combining the studies. As Summit previously communicated, it has combined the Phase III studies into a single study and will provide the combined results to all stakeholders, as the top line results become available. “These top line results will best inform all parties as to the next appropriate course of action regarding ridinilazole,” the company said in a regulatory filing. Summit anticipates communicating these results during Q1 of 2022.
previous post
next post