NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I updated my table for external contemporaneous control groups for all completed Phase III clinical trials for newly diagnosed Glioblastoma.

As we all know, the new Primary Endpoint for the DCVax-L trial is:

to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma

As it turn out, according to this article:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6280141/

there were only 8 completed Phase III clinical trials that were initiated for Glioblastoma between January 2005 and December 2016. Out of these 8 Glioblastoma clinical trials, 4 were for recurrent Glioblastoma and 4 were for newly diagnosed Glioblastoma. That means there is only a small finite number of "contemporaneous trials" that NWBio will be able to use in its TLD analysis of the Primary Endpoint.

As we all know, the DCVax-L trial started with its first patient randomized in 2007 and the last patient was randomized in 2015. All of the clinical trials on this Table are "contemporaneous trials".

Based upon my analysis of the completed "contemporaneous trials" for newly diagnosed Glioblastoma, the DCVax-L Phase III clinical trial will easily meet its Primary Endpoint: