NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

Milner, due to the FDA we can't see what PURE SOC does in this trial because FDA required that researchers advise all Placebo (SOC) patients and all them to Cross Over to using DCVax-L as soon as they progressed. Furthermore NWBO was required to use DCVax-L on top of SOC and not in place of it.

Given that GBM is a pretty lethal disease (regardless of subtype), which do you think the more plausible explanation of improved Overall Survival is?:

1. NWBO somehow cherrypicked the best GBM patients to juice the OS?

Or

2. DCVax L is the reason why most GBM patients in the study are experiencing longer OS (it will be interesting to see the difference in OS between patients who started on DCVax-L from Day One and those who only got access to the real thing after progression).

I go with #1 but there is no telling whether the FDA will punish NWBO for the outcome of placebo living longer, even though but for the FDA we would have had a pure comparison between SOC + DCVax L and SOC + Placebo.

So ironically, you might be right about Phase 3 being a total failure with PFS not being good enough and the OS results being viewed negatively, even though you would be right for the wrong reasons.