ae kusterer, I don’t think that NWBio was waiting for this article, because I believe that NWBio has been having direct discussions with the FDA in 2018, 2019 and 2020, about the DCVax-L Phase IIII trial interim results, and the fact that about 86% of all of the trial participants (treatment group & the control group) received DCVax-L.
I believe that the DCVax-L Phase III trial revised SAP and new Primary and Secondary endpoints were drafted as a result of NWBio’s discussions with the FDA, and guidance given by the FDA.