1. Yes marketing gets involved before Phase 3, but they tend to not have the clout they have going into Phase 3 - generally when it is unclear that you have som

1. Yes marketing gets involved before Phase 3, but they tend to not have the clout they have going into Phase 3 - generally when it is unclear that you have something that works at all it hard for marketing to argue in favour of broadening the inclusions criteria. 2. I think your point 2 is where we disagree the most. We are really arguing over what is a significant change or not. 3. The FDA will be looser on some things like age and other diseases (within reason as you won’t get approval for children if you only trial in adults), but not on sub-groups. If you make your trial exclude on some disease sub-group criteria you are not going to get FDA approval to go outside that sub-group and sell to everyone with the disease. Who is driving trial broadening other than marketing? If I want the drug to succeed I want the trial population to be a homogeneous as possible and only include likely responders.