Replies to post #155755 on NorthWest Biotherapeutics Inc (NWBO)

[jammyjames]

on a related note do you think the FDA/community's working definition of futility is changing? I mean it made sense to give a futility rec at an IA in the old days of chemotherapy when you're just expecting to shift the KM curve to the right - if it hasn't shifted sufficiently by the IA it's very unlikely to result in a stat sig HR by the end of the trial. But these days with immunotherapies and the long (fat is a better word) tail you can still easily end up with a stat sig HR at the end of the trial even if there is no or little distinction between the arms at the IA.

[longfellow95]

You don't understand the difference between "failure" and "futility".

To all intents and purposes they amount to the same thing here.

Any DMC that understands immunotherapy response kinetics (likelihood of pseudo-progression, delayed treatment response, long-tail survival) would be very unlikely to deem this trial either futile or a failure at an early interim stage, where the median data was far from being reached.

And if AF knew anything about immunotherapy, he would also know this to be the case.

He might know this, but it doesn't fit his narrative!