NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

OS was always an endpoint... although yes, it had been the secondary, with PFS as the primary.

What's changed as that OS has been moved up to the primary. Being that OS is the gold standard, and that PFS was intended to predict OS, and finally, that it's been determined that PFS cannot predict OS in this treatment's case, I believe it can be strongly argued that the trial has moved to the confirmation endpoint, which was intended to validate the PFS surrogate endpoint.

From the source you cite:

Questions to Ask:

What is the source of the new information that triggers consideration of a change in endpoints?

Have interim data on the endpoint (or related data) been reviewed?

Who is making the decision to change endpoints? Are trial sponsors involved, or is there an independent external advisory committee?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1852589/

Question one:
While the source of new information may be the DCVax P3 trial, it may also have come from other sources such as UCLA's trials, which are outside of the trial.

Question two:
The company claims that they have been blinded to the interim data. You can argue that they weren't, but readers should consider that IMO, that simply boils down to the opinion of a rando board poster with an always negative take on the science and the company. Additionally, if everyone privy to the blinded data were seeing that larger than usual multiples of patients that had been deemed to have PFS evented, and then their tumors were disappearing and they were going on to live much longer, they would likely have hypothesized that the treatment was having some sort of effect (especially given that the indication is the killer GBM). Still, due to the quadruple blind, no one would know the randomization status of the patients.

Question three:
We know that the trial sponsors had both an outside steering committee and an SAP to advise them.