Replies to post #434917 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

The trial can only be stopped if you have enough patients and evidence to prove a drug is effective. While I do believe that one of the non-US regulators disagreed with the FDA on the use of the placebo in this case given that placebo patients we’re doing so much worse, I believe, or that they were likely consistent with the SOC, and that would be unethical experimentation, I have never said it was stopped because they proved efficacy. Two different things.

[exwannabe]

Bio,

It's my understanding that a trial can be stopped early if the DSMB monitoring the trial goes to the regulators independently. If after discussions they're told to continue the trial, I'm uncertain if anyone ever knows that the regulators were contacted. I can't say if this may ever have occurred in the trial.

Garry, a trial halt can for efficacy or futility (or other reasons, not relevant). The DSMB makes a recommendation to the company. These are based on predefined rules set by the company, but the DSMB is free to act on their own. The company is not required to abide by the DSMB recommendation. NWBO did not halt the trial back then.

A trial hold (of any sort) is placed by regulators. They are based on safety/ethics.

As far as the German issue, they had very few patients and for a very short time. Of the 72(?) trial sites there was a single site in Germany that had been open long enough to have any data.

BTW, the idea broached by some that the placebo was a safety issue is funny. But I doubt anybody will know why.

[biosectinvestor]

Re confidentiality. Definitely an issue for the regulators and you are absolutely right on that point as a general from my perspective. The FDA is very much aware of how important, for numerous reasons, it is to keep everything absolutely confidential.