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Re: PacificNW post# 53179

Tuesday, 02/09/2016 4:09:10 PM

Tuesday, February 09, 2016 4:09:10 PM

Post# of 689593
You wrote:

The other issue did NWBO choose the wrong trial endpoint. I find it interesting that this comes out now, i.e. all invested in the company knowing this yet it didn't bother or stop anyone from investing in NWBO nor did it stop NWBO from moving forward with it. They knowingly chose this endpoint as we knowingly invested in their choice. There had to have been many reasons for them to chose one over the other besides solely ethics. Maybe this point needs to be discussed, why would one chose this endpoint over the other when now it appears they were fools for doing so....is it now so apparent knowing what we know now. --- Afford



I am not convinced that NWBO chose the wrong endpoint. Even AF admits in post 53106:

The study's primary endpoint -- PFS -- will not be affected at all by crossover since patients don't cross over until progression. Crossover does potentially hurt OS analysis, as Dr. Liau points out. - AF



I still believe that PFS will be an endpoint that can show efficacy much sooner than OS endpoint would.
OS endpoint might lead to a more definitive conclusion, but at a certain point of PFS improvement between placebo & treatment arm it would also be hard to dispute efficacy ... for the extreme say that median PFS of placebo patients was at 6 months and median PFS of treatment was at 24 months .... or an 18 month improvement.
And all they need to show per the current protocol is a stat sig improvement of 4 months.
Then it would not matter that OS is somewhat "confounded" because everyone is living longer (including early DCVax versus late DCVax).
What if it was found that the median OS currently sits at 48 months, and many patients remain alive after 5 years?
Pretty hard to imagine the FDA turning down DCVax-L in that instance.
So no, I do not agree with AF hype about PFS Primary Endpoint being a mistake.
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