MI Dendream, do you know whether Dr Pazdur has direct authority at the agency or is he a policy maker there, I cannot tell from his title. I am hoping he has direct authority as moving govt organizations can be a challenge that takes considerable time and effort. I hope to see the recent policies utilized and I know the agency likes to point to solid examples of new actions. NWBO is positioned well to suit their change purposes, appears to be a model except for the length of time, which may be more difficult to match surrogate metrics across other trials for external controls. Using OS simplifies this out of the block though.
GLTA