Replies to post #544633 on NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

WHAT??? so now, two unrelated events mean the RAs have approved the changed protocol ??? wow that is bizaare

[exwannabe]

Misleading. MHRA explicitly approved the trial protocol by green lighting a pediatric trial using the same SAP and the FDA implicitly approved the design by Finalizing their guidance on ECAs.

That is so wrong on so many points.

First, all the PIP approval says is that they have submitted a plan to investigate the drug with kids. It says nothing about it being worthy of approval.

Second, it is not the same SAP. Not even close. Just because it uses an ECA does not make it the same. The trial would be prospectively designed to use an ECA, which addresses several huge holes in the P3 change to an ECA well after the trial was over.

Third, the FDA guidance on ECAs isn't finalized. You are talking about their guidance on RWD which is using data from outside of trials and has nothing to do with the DCVax-L use of an ECA.

Fourth, the FDA guidance and paper posts several large concerns about using ECAs the way NWBO is trying to do.