NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

The trial was long because they cherry-picked the healthiest patients with GBM in only one hemisphere. It also took longer because FDA stopped the trial for TWO years. It's only a 5 year/60 month trial either way.

The TOTALLY NEW protocol wasn't APPROVED by the FDA -- Read NWBO's SEC 10K filing -- they made all the changes at risk. FDA doesn't approve changes, they only reject them it they risk patient safety. Ashcan doesn't deal with FDA, the company does.

NWBO confirmed this in their SEC 10K annual report: "the endpoint against which the data is measured must be acceptable to the regulatory authorities, and the statistical analysis plan for how the data will be evaluated must also be acceptable to the regulatory authorities. The statistical analysis plan that we submitted to regulators for the Phase III trial embodies a different primary endpoint and secondary endpoint than did the original Protocol for the trial. Under the Protocol the primary endpoint was progression free survival, or PFS, and the secondary endpoint was overall survival, or OS. Both of these endpoints were confounded: the PFS endpoint by pseudo-progression, and the OS endpoint by the “crossover” provision in the trial design, which allowed all of the patients in the trial to cross over to DCVax-L treatment after tumor recurrence (while remaining blinded as to which treatment they received before tumor recurrence). The statistical analysis plan uses external control patients rather than within-study controls. There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach.:

FDA requires sponsors file protocol changes, but FDA doesn't approve them.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-protocol-amendments