NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Cross-over was rescue medication when the treatment failed -- it is an ethical requirement for patient treatment. The treatment failure was defined as PFS for both treatment and comparator arm. From the trial protocol: "All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression." That's rescue medication.

The trial was a NAIVE GBM trial with nothing in the trial design for recurrent GBM other than the recuse cross-over treatment. The trial name: "Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer (GBM)" -- note, nothing about recurrent GBM.

The rescue crossover resulted in nOS confounding as now treatment patients were double dosed. The rGBM was post hoc data dredged data they were forced into when they tossed out the original primary endpoint and needed another efficacy endpoint.

You mean the FDA that was uncomfortable enough with how NWBO operated the trial that they put it under a partial hold?? FDA doesn't do that unless there is something seriously wrong. And NWBO kept silent on the cause of the hold -- no SEC filing explains it, no investor call, no nothing, just crickets. NWBO got out of it by agreeing to close down recruiting -- that's all. Is that your definition of "consultation?" No FDA Guidance supports totally redoing the trial protocol AFTER the trial is completed -- new protocol/SAP, endpoints and comparator. FDA has "approved" it as NWBO's SEC filing repeatedly show they did all the changes at risk.