PAA, A New Dawn , FDA ODD Approval and Entering Phase II MND Trial, page-276

One thing that crosses my mind is that the patients going onto the OLE study have ALREADY been dosed. They have been receiving MPL since they started the phase 1 study. They have been on compassionate use since then (this speaks volumes obviously!). So for them to go onto the OLE is really just for us. They probably have to undergo a battery of tests, questions and inconvenience (time and travel) before we can officially say that they are now on the study. But really, what do they receive that they are not already getting? They are already taking MPL so no extra benifits, they are simply helping us and so I'm afraid we'll just have to wait until they are feeling up to adding even more stress into an already very difficult time in their lives. Maybe a bit more empathy and understanding from us is required?