Doc,
If I am following your logic correctly, you are suggesting that randomization took place but that those randomized to placebo (I.e., SOC only) were not enrolled. Thus 331 instead of 348. While I applaud your outside the box thinking, I can say with experience and reasonable certainty that this did not happen. Randomization is double blind, no one knows who gets what except the individual administering the code and even then the participant is also coded so as to remain blind to them.
I am sticking with my theory that dates back to August 2015. Here it is more clearly defined than my previous post on the subject: A futility analysis was performed summer of 2015 (interim analysis in layman terms), and a recommendation to stop the trial was issued by the DMC. Since it was for a difference observed in blinded cohorts rather than futility, FDA was brought in to evaluate the data. The data can remain blind at this point because approximately 55 PFS events per arms tells you one arm is doing 2x more poorly than the other. While FDA signaled stopping the trial would be met favorably, Linda stated publically that she wanted to go all the way to OS. She also said the halt was good news and invested hundreds of millions in capacity expansion. If I am to believe the recent ASM transcript she now also stated that documenting a long tail survival would be historically important at this point
Go back to 2015 and recall that IMUC was anticipating OS results after a positive phase 2 trial result. Linda need to continue the trial so as to have a marketing advantage against and assumed positive IMUC trial. This is why she past on the bird in hand going for two in the bush.
Long and stronger than ever,
Michigan dendream achieved, Colorado dendream next ( a shout out to my DNDN boys who also achieved their Michigan dendream - I don't have time to call but since I know one of you is reading, get on this train fast...it is heading to Colorado for a ski villa soon)
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