Sentiment, you ignorant slu.! Just kidding! Just seeing if there are any old people on the board. What you say here makes a lot more sense than what I said. It describes a more meaningful comparison and one with better odds of a good outcome.
"I’m not sure if you’re thinking that the new end points intend to compare all patients who received DCVax (so treatment and part of the control arm… early and late) to an external control arm (ECA)… but if so, that’s not the case. They’ll be comparing the treatment arm (early) to the ECA. Then the control arm that did receive DCVax (late) will be compared to a recurrent GBM control arm.
What I really like about this is that everyone’s data is used. I would like to think that is of some consolation to the families of those in the trial who are no longer alive."
Winning in rGBM would be super phenomenal. That's like a prize fighter beating an opponent w one arm tied behind it's back. In DCVax's case, the 1 arm tied behind it's back is new mutations and greater tumor burden. A fair fight would be using resected tumor from recurrent growth.
My prediction, rGBM is positive and will be covered under the label, but there will be a post-marketing commitment there. No biggie at all, but a commitment none??the??less.