NorthWest Biotherapeutics Inc (NWBO)

[User-840664]

<<<They got permission >>>
From Whom?
<<< very thoroughly vetted, externally proposed, expertized, blinded placebo based >>>
LOL, external controls were bogus! IMO and other scientist's opinion.
Are these the reasons they applied to FDA and EU for approval?? Clown. Your stock is barely holding 46 pennies

From the JAMA filing…
“Given the careful screening to include more favorable patients without signs of progression, we ask the authors to consider presenting complete data for the placebo arm for direct comparison as specified. Despite the urgent need for more effective therapies in glioblastoma, the absence of an ITT analysis suggests that this is a negative trial and that the reported findings are exploratory..”

Autologous tumor lysate-loaded dendritic cell vaccination (DCVax-L) in glioblastoma: Breakthrough or fata morgana? Preusser, 2023

"An initial report on the trial in 2018 reported only on the combined overall survival (OS) data of both study arms and failed to report on PFS, the primary study endpoint. The argument for not publishing the primary endpoint was an ambiguous statement about an expert panel being required because of the complex determination of progression.

Now, more than four years later, a second report is available, which is surprisingly named “A Phase 3 Prospective Externally Controlled Cohort Trial”. This is a remarkable title, as the investigators have re-analyzed the OS data of the study against published external controls and present this as a prospective trial. It is obvious, however, that this is not a prospective analysis but a post hoc retrospective analysis: the investigators had seen the data, both of their own study and of the cohorts taken for comparison and then decided to go ahead with cross-trial comparisons."