Replies to post #151022 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

chinatown1980,

Yes, FDA imposed the halt in the US. At least that is what is understood from the wording surrounding this event but the wording with regard to Germany appeared to indictate a voluntary enrollment halt was or might have been initiated there as I recall. I do clearly remember discussions about this took place on this board and elsewhere after the halt was imposed. I expect we will be able to go back and find the pertinent references but I am positive this discussion took place and sources shared. Best wishes.

[flipper44]

Maybe I missed something, but I don't recall seeing anything indicating the Germany halt was voluntary. Please provide your source -- Chinatown

Yes, you missed something.

The trial was on partial clinical hold for screening of new patients for enrollment; however, the patients already in the trial continued to be treated in accordance with the trial protocol, without interruption. In December 2016, the Company announced that to date the regulators had not agreed to remove the partial hold, and the Company had determined that it would not enroll the last 17 of the planned 348 patients. Thereafter, in February 2017, the FDA lifted its hold. The Company had self-imposed a hold on screening in countries outside the US, this remains in place in agreement with the regulators, and the Company will not enroll the last 17 patients as announced in December 2016. -- 10K