snoopycomic,
Informed speculation but yes, speculation. What is not speculation is the claim in the Direct patent to be able to identify responders before giving them any treatment based on whether or not there is the ability to manipulate DCs to certain levels of cytokine secretion produced in them. So if NWBO had pretty much a sure thing in Direct would NWBO continue on with L in 2014? Remember, that decision would have been at least partially based on less than promising data from December 2013 at PFS 66 from the early enrollees that may have been the result of a higher than normal percentage of unmethylated MGMT status patients. This decision would also have been affected by the same type of thinking that led to broadened absolute lymphocyte count patients in 2014 so something was convincing them to move forward with L and that is when the Germans came on board. I believe the guidance for adequate and well controlled trials by that time was already taking into consideration that pseudoprogression had become a serious issue with defining progressions based on old standards and that a process to petition for adjudication of PFS endpoint was put in place. So with Phase 3 being expanded in 2014, the Germans coming on board with HE granted and adjudication of PFS available NWBO moved forward with L. The question is what did they all see between December 2013 and the end of 2014 that got them and Mr. Woodford excited? Well we know their understanding of DC maturation improved with their findings from Direct Phase 1. Maybe, just maybe they were seeing a relationship develop between treatment, pseudoprogression like response and survival in a significant number of patients. Best wishes.
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