In a perfect world, we would have the dataset of a double-blind placebo test comparing OS (overall survival). Unfortunately, this is not feasible for a few reasons:
-Since untreated GBM has a 100% fatality rate, it would be unethical to deny someone access to a non-toxic treatment that might actually save their life.
-Does the FDA really need to wait another 7 years for the trial to be redone just so they can get a slightly cleaner-looking set of data points? The difference with DCVax is pronounced, and the therapeutic is clearly saving lives. Do another 50,000 people need to die of GBM so we can get a slightly better looking survival curve? If the treatment had chemo-style side effects, I could see a point in this, but DCVax is also NON-TOXIC so there is really nothing to lose from a patient's point of view.
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