NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Even if thats true, which its not the trial was blinded when endpoints were changed, then still thats well within FDA/EMA regulations.

There is no regulation saying what endpoints changes will be suitable for approval. The only absolute rule is that changes must be safe an ethical for the patients.

On the issue of changes being suitable for approval, this article is a good starting point for understanding the issue.

Guiding Principles
The principle consideration when evaluating whether to modify an endpoint is whether the decision is independent of the data obtained from the trial to date.

If the decision is even partially based on an IA then it is not independent of the trial data. If NWBO knows the PFS endpoint failed in 2015, then changing it later will be presumed to be influenced by the failure.

Further, the OS endpoint change, they flat out said it was based on data from the trial. The high crossover count was data form the trial.

On the issue of the a futility finding on PFS in 2015 this is obvious.
. There was an efficacy IA in 2015, that is a fact per the JAMA paper.
. Given the PFS failure, a futility finding would be expected.
. The FDA actions on the partial hold are 100% consistent with how they treated CVM with a known futility recommendation
. LP said she was trying to trying to get enrollment restarted.
. LP has never denied it.

You are free to believe it did not happen. I would be stunned if it was not the case.