NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

sentiment_stocks,

The trial design was the best that could be done out of concern for patients and that included the crossover. However, randomized trials are not supposed to set up with active experimental treatments going to SOC/placebo as that will skew results and this one was because of influence by regulators regarding the invasive nature of leukopheresis and patients wanting to know they would have a chance to get the treatment at some point.
With everyone apparently living longer and PFS messed up with SOC and treatment induced pseudoprogression leading to SOC/placebo patients crossing over before true progression and actually becoming more like best scenario treatment arm patients, the measures of treatment effect and endpoints had to be changed and FDA recognized their part in creating the problems that indeed were best for the patients but not good for clear cut trial parameters and measuring tools of treatment effect.
Regulators realized they needed to make some changes and their guidance was updated to reflect what they were learning from NWBO and others working in cell therapy and other immunotherapy situations. This is why we have seen so many regulator changes being made since 2015 especially and some look tailor made for what NWBO needs as we have noted at times over the years on this board. Best wishes.