Tuesday, February 09, 2016 4:09:10 PM
I am not convinced that NWBO chose the wrong endpoint. Even AF admits in post 53106:
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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