NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Not sure the FDA would have given them a certain answer if there was something they didn't give unqualified approval to.
They could have, for example, advised that NWBO retains PFS as primary, but at the same time indicated that they would be willing to bring into their considerations, the adjudication of PFS calls by an expert panel.

In this 10-K, NWBO came out and said themselves as clear as day, that PFS was confounded by pseudo-progression, and OS was confounded by crossover. Not sure that they have done this previously. If they have, I wasn't aware of it.

The FDA might have made proposals as to how to they think that the confoundment (now openly acknowledged) could be mitigated, in what they consider an acceptable way, but at the same time possibly not gone as far as to give their unqualified approval to the endpoint changes that now show on Eudract for the UK and for the EU.
Something like a halfway house, if you like.
Or just some sort of commitment to consider the data in its entirety (including giving due weight to the unprecedented survival durations of a significant percentage of trial subjects).
They've always had the right to basically override their own statement on adequate and well-controlled trials, if they believe special circumstances apply.

No, I'm not alleging fraud.