NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

I do also have the impression, based on the blinded results published, that DCVax-L will prove to have decent/good/great efficacy for certain patients.
However, you wrote:

Further, I believe that even though DC VAX L may prove to be more efficacious for certain groupings, the FDA will provide a blanket approval in line with Dr. Ashkan's clinical assessment that the vaccine should be made available to all patients as it works to a greater or lesser extent across all groups.
The decision as to whether to use DC VAX L as an adjuvant to current SOC should be a decision reached between patient and physician rather than circumscribed by regulatory fiat

It might not make sense to provide DCVax-L to “anyone with GBM” if the results indicate that the vaccine is only very effective for a certain subgroup of say 20% of patients, but perhaps merely “somewhat effective” for say another 50%, and ineffective for 30%. IMO it would not make sense to provide the treatment to this (hypothetical ) 30% group of patients for which the treatment is likely ineffective.
The anticipated cost for the DCVax-L is likely over $100,000 per patient, and if the results indicate it would be unlikely to benefit a certain subgroup (hardly) at all, then that would be “a waste of money”.

Years ago, I seem to remember that Linda Liau indicated that DCVax-L would be relatively ineffective if SOC treatment was not provided provided prior to DCVax-L vaccine. Again, if DCVax-L would be relatively ineffective in that scenario, then it would make no sense to spend $100,000+ on the vaccine treatment. Thus the decision whether to use DCVax-L as an adjuvant to current SOC should not be solely a decision between patient and physician (unless the patient is paying for the treatment out of pocket). I guess this is what the UK regulatory bodies try to gauge in advance: the cost of the treatment versus the expected improvement in the medical outcome. If the expected outcome is too small in relation to the cost of the treatment, then the limited funds would be better spent on something with a higher anticipated success rate.