biosectinvestor,
It does appear the science behind cancer and the science and technology behind DC's are converging now and it is an intuitive connection that is very interesting, particularly when you view where NWBO is, which is why I am somewhat disappointed that they are losing R&D time. There is a high need for this article to be published asap just to get things moving. And, I am hard pressed to understand there is much additional value in not concluding the trial this spring as they have already collected, as needed in this case, more than most trials while remaining blinded. I am convinced they have held the trial open this long because of the platform and not just L and not just for GBM, though using L for GBM is their critical first step. I see the second and/or third step as the much bigger one and they are trying to simplify it.
That all being said, I am always disappointed it is up to us to try to connect these dots. And, I cannot see NWBO continuing this trial in blinded fashion beyond this spring, given the last patient enrolled is now beyond the 'home run' mOS point of an estimated 24 mos to 26 mos.
I believe FDA will not do anything if NWBO wants to continue the trial to collect data as they are limited in what they can do even if they are offering a pathway to approval. NWBO has the right as the trial sponsor to continue the trial as long as there are no safety or ethical issues, though we would all argue it seems unethical to hold DCVax-L back from the market a day longer than necessary for GBM patients. If NWBO is extending the blinded data collection period for the sake of the platform in the big picture, and, they are not worried about short term financial challenges, it will work out in the end. Like most here, I am hoping the beginning of the end, if you will, starts this spring and I believe it will.
