Replies to post #94089 on NorthWest Biotherapeutics Inc (NWBO)

[BWIS]

And I thought confirmatory trials were phase IV not phase II.

[flipper44]

You missed my first post on this matter. For a long time, I was waiting to see whether any such phase II trial would be announced before phase III results and have an arm that was soley for DCVax-L. It does. It is a good sign. Generally, the FDA wants confirmation trials started before they rule on AAs.

Except it makes no sense. How would a combo trial confirm anything about vax L on its own? -- Chinatown

Overall Survival (OS) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
The overall survival curves will be displayed using a Kaplan-Meier curve for the pooled and individual treatments. A one-sample log-rank test will also be completed as a sensitivity analysis for the same survival rate assumption as the primary efficacy analysis, and a two-sample log-rank test will be used to compare the survival distribution between the two arms. clinical trials.gov