Ventrus has submitted a new SPA that includes a revised protocol, including the newly defined endpoints, in accordance with the feedback received from that meeting, and expects a response within 45 days, which is the customary FDA review period.
Ventrus CEO Russell Ellison said they are very pleased with the new endpoint definitions in that they showed considerable differences between active drug and placebo in our analysis of an earlier Phase IIb study in Germany, which has been the cornerstone of our development program.