NorthWest Biotherapeutics Inc (NWBO)

[Adam_Feuerstein]

The DMC does not have the authority or power to alter the design or conduct of a clinical trial on its own. Only the drug sponsor can make changes to a clinical trial.

There would be no reason to make changes to the DCVax ph3 study based on blinded interim safety analysis. The only reason for the changes made was because the interim efficacy analysis was conducted and came back showing DCVax to be futile, or at best, just barely maintaining a difference from placebo above the O'Brien-Fleming boundary for the PFS primary endpoint.

As a hail mary attempt to save the study, Linda ordered changes made. Enlarging a trial is not done for any other reason than because of a weak or non-existent drug effect.