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BWIS

02/12/16 2:44 PM

#53566 RE: Doc logic #53563

Yes, but in the trial, you would only cross over if you had an event or figured out you were on placebo and left the trial. Then they shouldn't be part of "all".

Also this is assuming crossover means placebo or dcvax to no treatment. Don't believe this is accurate assessment. IE why would FDA demand crossover to Nada for compassion sake?

Anyway. You before stated it as fact and now backed off to "in my opinion". Big difference right?
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Evaluate

02/12/16 3:51 PM

#53584 RE: Doc logic #53563

You wrote:

Dr. Linda Liau said "all patients are living longer". She then went on to say "hopefully" with regard to crossover option patients who didn't get anything, ie. DCVax, and may have gone on to other treatments without it. In my opinion, it is these patients who, as a group, are receiving some benefit from treatments like checkpoint inhibitors and are part of the "all", that she hopes will show that DCVax treated patients will benefit more than. --- DocLogic


How many patients (from the placebo arm or the treatment arm) that have a disease progression (PFS event) do you believe would NOT ACCEPT the crossover option, but rather drop out of the treatment part of the DCVax-L trial and decide perhaps to try something else?
My gut feeling is that nearly 100% of all patients that progress and are offered the crossover option will likely accept it. IMHO.

I believe these patients are also allowed, after they have had their PFS event, to crossover & be assured they start receiving the real vaccine, BUT ALSO (at that point in time) be allowed to seek other/additional treatment. So for example, if a patient receiving treatment at UCLA had a PFS event .... could this patient then perhaps also receive some adjunct treatment as perhaps recommended by Dr Liau & her team .... or receive some treatment combining a checkpoint inhibitor or *other*?