I'm curious to hear opinions on how the changes to the P3 trial design will effect the results.
In previous trials patients were stabilized for only 3 days on 12-16 mg oral, but many used at least some rescue medication. In the current design patients were stabilized for 3 months on 8mg or less. However, no rescue medication will be allowed this trial.
I think it will be interesting to see how it plays out. In my mind the 33%-50% reduction in required dose should counter balance for the use of rescue meds. Also, these patients were not using 3 days before starting the trial. So they should be a lot more stable. I am anticipating results in line, non inferior, with previous results.
What are your thoughts and opinions on this topic?