Thanks for that Stillwell.
It might not matter at the end of the day, but the
crossover issue has not been fully resolved here.
RK's post 52892, that Flipper referred to, seems to adequately demonstrate
that after post progression crossover,
the blind is not maintained, and that it moves to open label status.
However your previous status prior to crossover remains blinded.
At this point, as a patient, you can elect to continue to
receive injections within the trial, and you know that you
will then definitely be receiving DCVaxL. if you run out of
lysate, and they don't substitute the placebo, you will be able
to deduce what arm you started out on. But the important thing
is that the blind will have been preserved up until crossover.
So measuring of the Primary End Point (PFS) will remain
statistically sound. The OS data will be somewhat muddied by
the fact that all subsequent data will be open label, and
doctors can employ any 'established treatment' in addition to L injections
post crossover.
From NWBO's point of view, it is critical that 'progression'
is/was accurately measured, and that pseudo-progression
is not mistaken for actual disease progression, given the
primary endpoint. I sure do hope that the assessment mechanisms
were sound. It is not surprising that Dr Bosch recently
referred to pseudo-progression as a confusing factor for
trials generally.
And pseudo-progression is generally a positive prognostic indicator
of better outcomes!
Market Data 
Markets 
AI
