Replies to post #142426 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Thus, FDA said "say what?, you really want to wait? We recommend that you don't...wink, wink. Say what? You want to go all the way to OS? Your choice but we cannot let you put anyone else on PBO, that's just not ethical. You can have the patients that already consented and no more. If you want more, you will have to run an EAP and give it away, give it away, give it away now.

It is up to the sponsor to stop or continue on either futility or efficacy. There is no "wink", the FDA will just gives advice.

What is the "ethical" here if the drug was clearly working?

A) Trial completes screening, 22 get wonder drug, 11 get current SOC with possible x-over.

B) Screening halts, 33 get standard SOC and no chance of x-over.

Why is B more ethical than A?

BTW, have no clue what you are talking about with EAP. That program shut down with the halt.

Reality bytes.

[flipper44]

You are correct, I misinterpreted the phrasing in your final passage, so great, welcome back Dendream and Highwayman. Guess you never left. I too personally believe they likely had success at the first interim, but I’m not as confident regarding the reason for the screening/partial halt. Part of the task of phase iii trials is to also demonstrate commercial validation is up to speed, and that is where I fall regarding the reason. It’s not a popular reason, but I’m sticking with it unless we find out something different. Either way, the partial halt was lifted.I do think their admission they voluntarily halted in Germany might be more related to Germany’s tight restrictions on giving placebos when a therapy is proving efficacious.