NorthWest Biotherapeutics Inc (NWBO)

[Galzus Research]

The Phase 3 L trial started well before pseudoprogression was fully established as an issue with determining progression especially in conjunction with immunotherapies and with radio imaging at that time that was not able to completely distinguish the difference.

Yes, but that is not a suitable justification for switching the primary endpoint of the study. Note that other immunotherapy studies circa 2014-2015 were failing to show a PFS benefit (one example here: https://www.nejm.org/doi/full/10.1056/NEJMoa1507643). That did not stop them from getting approval on the basis of OS, although those studies had a proper randomization to corroborate the OS benefit observed.

Prasad would be foolish to single himself out for ridicule due to prejudicial bias based on historical comments leading into any alignment with your interpretation of his statements that led to any interference by him with a BLA submission by NWBO.

I don't think he would interfere with a submission in any way. But, like Marks, he'll have the ability to intervene on things, and his hewing to rigor in clinical trials would be a pretty negative factor against DCVax-L with the data as it stands.

Interestingly your comments now lay the groundwork for no further comment by him in this regard and the basis for him to recuse and distance himself completely from this one much to the chagrin of the influence peddlers; ).

I think the only reason he has not been public about DCVax-L in the intervening years is that it hasn't made much of a splash at all in the world of oncology experts. Had it been submitted to the FDA prior, we might have heard further comments from him. And now it won't be until a BLA submission that we might get any indicators from him, but the fact that NWBO has not submitted that application is telling all its own.

I do not think he would recuse himself from comment about DCVax-L, specifically. Perhaps he's going to tone down and quiet on all fronts as he gets to work. But in the years I've been following him, there's nothing he's said that gives me any confidence that this trial, if it were to actually register as something, would be adequate to justify approval.