NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

SAP needs to be approved before they unblind. After they unblind, they go to data lock.

As for adjudication, thinking about it, I'm thinking that the adjudication must have happened before they submit(ted?) the SAP. It's logical to think that the adjudicated data is what accompanied the SAP to justify why they were revising the SAP.

Remember back in February 2017 when they announced the screening halt had lifted in this PR, and that they'd reached the number of PFS events? They indicated in that PR and in a few other 8ks that they were checking the MRI images.

The process involves in-person monitoring visits to all of the 80-plus sites in four countries to review the files onsite, as well as other documentary confirmation and checking of all MRI images.

Now if the halt were to do with the pseudoprogression issue (and maybe it was pushed into existence by a very aggressive DMC head with a robust COI), then there would be no other way to resolve it (and get it lifted by the FDA) then to convince the FDA that the patients who were living longer after seemingly having progressed, really had not progressed, and that there needed to be another means by which to measure progression for these patients. The only way to convince the FDA of this would be to look at what? Well... the MRIs.

So after stewing on it a bit, I think it's very likely the adjudication took place already, and that is the reason the SAP is being changed. So upon SAP approvals, they should be able to unblind the trial.

Whew. I feel better about the time line now. The idea of having the adjudication in front of them - which would take anywhere from 6 months to a year - sounded, well, not so good. Having it behind us sounds much better.