"Yes the problem is they will need patient level data from external control arm also for FDA, not just the patients in compassionate use arme"
Problem Mani is that most likely a substantial number of patients in the compassionate program received not only DCVax-L but also poly-ICLC and the resultant mOS figures may be longer than the ones ever seen by the FDA. I can only guess what the FDA's reaction would be. What is your guess?
My guess is that the FDA will be more interested in the results emanating from the compassionate care program than the results demonstrated by the external control arm.
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