Can Sponsors Respond by Finding Non-Responders?
This article was originally published in RPM Report
Executive Summary
One way to get a more favorable review from FDA is to find products that work on a well-defined, under-served patient populations. Wyeth R&D head Robert Ruffolo has some questions about how difficult it will be for sponsors to find those populations. Here is what he had to say about the difficult time-frame for taking a non-responder strategy.