NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

I am still waiting for your superior trial design of the DCVax-L trial
that takes the FDA crossover mandate into consideration.

I tried to come up with a better trial design and couldn't because limiting
the trial to a comparison of time to progression (mPFS) does not work because
of the powerful pseudo-progression effects inherent in the DCVax-L Treatment.

A comparison based on mOS does not work either because DCVax-L also greatly benefited
the 64 crossover patients and that demonstrates that absent the FDA's mandate to
allow patients to crossover, the mOS comparisons of the two arms would have shown
a statistical significant survival advantage for the Treatment group but eventually we
would have discovered that with regards to ethics, this trial failed miserably.

The takeaway is that placebo arms can often not be used in immunotherapeutic
trials. The MHRA obviously understands this. In fact, why has this regulator
recently asked medical professionals for their opinion concerning the utilization
of RWD in lieu of placebo arms?