Was the complicated titration protocol used more for dose finding? Assuming that case was the case, once the process is nailed down, weren't they right to have recommended an easier titration procedure for real world practice?
At the end of the day, it is all about risk benefit trade off. We have a very favorable risk benefit situation with Tlando that would benefit a lot of patients. If FDA does not approve of this they will be doing a big disservice to the patient community.