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Re: Mionaer1 post# 392907

Monday, 08/02/2021 9:07:25 AM

Monday, August 02, 2021 9:07:25 AM

Post# of 821976

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.



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