The problem with those like yourself is that you think everything should be done the way it's been done for a hundred years or more. For a trial to be effective you must have a control group. Once you begin a trial, no matter what you learn, don't change it, let it fail and just start a new one, no matter how much it costs in money, or time. Let the people in the control group event quickly, that proves the trial product is working, rather than allowing all the benefits to all in the trial, and comparison with hundreds of years of data and previous trials with the same diseases.
The trial for DCVax-L will succeed because the regulators are open to change, they've supported changes throughout the trial, and once they consider the evidence they'll clearly see it's a step forward. I don't know if anywhere in what's submitted there are any references to the Phase 1 trials at UCLA, but I've got to believe the regulators already know all about them, at least in the back of their minds.
Gary
Bullish
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