NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

Does FDA have juristiction over German regulators or do they cooperate with them? FDA enforced the hold in the US where preplanned enrollment was already complete or very, very nearly so. Their decision had very little to no impact on planned for enrollment in the US. Germany was still enrolling and never gave their enrollment numbers. FDA's decision, therefore, helped encourage NWBO's decision to proactively prevent the German authorities from imposing the hold there and then disclosing the reason for the hold which they would have done if ethical reasons were involved. This all happened after the 2015 Spring Refresh of blinded data was done by NWBO. That data coupled with a DSMB look for safety obviously could have led to what happened based on German sensitivities and governance which has been shared often on this board. Besides this, Fraunhofer later claimed to have enrolled only to the point statistically necessary while never giving final enrollment numbers.

So, looking at this from your perspective, NWBO does their first Spring Refresh of data in the Spring of 2015, meanwhile DSMB does their own review and reports to NWBO and FDA then FDA imposes a hold and NWBO imposes a voluntary hold outside of US and maintains it to this day instead of seeking to enroll any more final patients in Germany because.. NWBO made an agreement with FDA? I don't think so. I think NWBO had enough common sense and technically blinded evidence to know what was going on and kept the voluntary hold in place on purpose to prevent long term data from being interfered with. There are still 17 missing SOC/placebo patients from this trial and they all or almost all certainly would have come from Germany. Best wishes