NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Same bias issue. Since the ECA trials included considerable # of patients with biopsy or partial resections as they were all acceptable for a # of ECA trials. NWBO trial required substantial resection when all or virtually all of the tumor was removed. NWBO deemed some as having "substantial disease" even after the substantial resection -- and many of the ECA patients still had substantial disease after a biopsy, A biopsy removes almost NONE of the tumor.
So that comparison still had bias in the nature of the screening.

This is the reason that FDA requires ECA comparator trials be selected, analyzed, reviewed and approved by the FDA BEFORE THE TRIAL IS STARTED. And why NWBO never filed the application with the FDA. FDA won't accept and AFTER THE FACT ECA.