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07/07/18 12:25 PM

#181574 RE: JRIII #181562

JR111,

I think you might be forgetting that adjudication comes at the end of the trial. They need time for that to occur before submitting all final data. The other potential reason is that NICE might accept OS data alone and in confidence to begin the process and then release all data publicly after FDA gets all data including adjudicated PFS. Who knows what they are working out between all the parties but my guess is that they will try to work something out together with the decision making process. I expect they will work with the most important parts of the decision making process relative to each regulator. OS is what is most important to a NICE decision because the Germans already expanded eventual use to all glios while FDA needs both PFS and OS to get the pseudos added in to the final analysis.

JR111 you said you were about 8 months ahead of schedule with your vision and angst. I get years ahead of myself and have had to learn to reign my excitement and wait for opportunities to arrive at the right time. Trying to make sense of a process that has had to make adjustments for accurate analysis of endpoint events is nearly impossible looking at it from the outside in especially when time becomes the friend of some patients and science but enemy of those invested. Best wishes.