Replies to post #392907 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

I'm 99.9% sure he's talking about the DC Vax-L study. This means that he was informed about the study at this point and at the same time provides a reason for the SAP change. Namely the mixing of the study participants through the crossover option....

He was not talking about a specific trial. He was talking about reasons why the FD is no longer as insistent on OS, and often considers RR and PFS instead.

That does not sound like DCVax-L at all as they are going the other way, replacing PFS with OS.

Why would a discussion of why PFS/RR is being treated more favorably be a reason to replace it as the primary endpoint? Why would ethics be a reason to change the SAP?

Pazdure has been saying this at least as far back as Dec 2017.

[ATLnsider]

I agree Mionaer1. I also believe it helps to explain the enrollment halt in the DCVax-L trial, due to a lack of true Equipoise for patients randomized to the control group.