NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

I would imagine that, in the case of GBM, the FDA would have a strategy for all relevant clinical trials in the event of disease progression, given that, until the genesis of DCVaxL, such a diagnosis was effectively a death sentence.
Any trial with a placebo arm must surely have built in provision for a crossover, or subject departure from trial. Anything else would be unethical.
The fact that the crossover on our trial means every participant will have the chance to benefit from DCVaxL, I take as a tacit sign that the FDA already recognises DCVax as the safest and most promising therapy.
Would you go on a CLDX trial if you knew you might be receiving a placebo without being afforded the opportunity to 'cross over'
If the CLDX trial is comparing SOC with SOC plus CLDX drug, then, in those circumstances a cross over may not be essential.