NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

It's sort of opposite to the Olympics in the manufacturing world. We went over and over this many years ago. If a biologic manufacturing process improvement (typically to prepare for commercial scale production) does something like get a higher purity of cells, you worry if the modification causes safety problems or adversely impacts efficacy. On the other hand if the impact is not adverse in either case, then one must look at these changes with a pragmatic eye toward the better outcome. If we do not handle these (potential) manufacturing preparations with common sense, then we continue to die. The trial has gone on long enough, that if there were manufacturing changes back in the mid-10's, preclinical bridge studies, plus the restraint on unblinding the trial (again to a clinical bridge study), has allowed the trial to provide ample evidence of similarity over the course of another four years -- even if the final result is somewhat superior.

Biology is so much more complex than anyone understands, and it throws curveballs and an occasional fat pitch. This time the pitch was straight over the plate. IMO. The Royal Society wrote a paper suggesting biological manufacturing enhancements for such qualities as higher purity should be simply treated as a higher dose.

The other fact is the use of 5-ala in guided surgical GBM resections may allow removal of more tumor tissue. Thus enabling DCVax-L to get the upper hand early.

Again, if regulators are rigid and inept, they'd simply reject any obvious improvements in outcome based upon otherwise obvious causation. Again, this trial has run on long enough, since any of those changes might have been implemented in the trial, that blinded followup is akin to a clinical bridge study in and of itself.

As a species, we must be smarter and think on our feet instead of continually throwing out the baby with the bathwater. New potentially life saving paradigms and the patients they might save demand better from us.