NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Slave1,

Ethics and statistical significance is almost certainly why the Phase 3 trial was not allowed to continue enrolling SOC/placebo patients after the blinded look in 2015. Enrolled to the point statistically necessary was what Fraunhofer stated in their 2015 annual report and the Germans do not allow experimentation on patients with a lessor known treatment regimen. Starting treatment with DCVax with a mesenchymal subtype tumor and or crossing over to DCVax after becoming mesenchymal signature was apparently found to be the best regimen as there is significant scientific evidence for this even outside of this trial. For this to take 10 years to get a pathway approved for cell therapy and it’s further expansion seems to coincide more with manufacturing obstacles being overcome creating the need rather than just recognition that something needed to change in guidance or law to accommodate a cell therapy approval starting 10 years ago, which could and should have been done then if artisan manufacturing was going to be considered cost effective and practical for meeting the need. Artisan was NEVER going to be that for a potentially tissue agnostic platform treatment and that is exactly what the IFR designation of cancer being changed from GBM implies is in the process of happening at some point and what Linda and NWBO have been claiming the DCVax platform is all along. Best wishes.