Not controlled enough. Just another escape hatch. What is so flipping hard about asking them them to provide the complete actual number of people actually alive (beating heartbeats) at three, four and five year time points from their phase III trial? The first two could be provided now, and the OS 5 number could be provided by December 28, 2019.
Is the FDA just going to let the scientific community at Novocure sell likely snake oil promises, or are we going to demand they tell the truth to patients about actual three, four and five year survival?
What in God’s name is the FDA doing?