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Rkmatters

06/27/16 7:05 PM

#65648 RE: Rkmatters #65645

I responded, as it occurred to me that NW Bio can use this biomarker after PFS point to prove the vaccine is contributing to survival. Upon crossover, the study is no longer in a controlled setting (departure from Stupp, no two patients treatment going to be exactly alike) and thus it is unlikely that regulators will approve a co-primary endpoint (if that's NWBO pursuit); unless they can be convinced that there's a way to confirm the survival can be linked directly back to DCVax-L. Anyway, this biomarker can be advocated to stand in for that. Time will tell if they try to use it somehow.

Not much going on as we wait for Phase III news. Enjoy summer. :)

Doc logic

06/27/16 9:47 PM

#65667 RE: Rkmatters #65645

Rkmatters,

That would be the gold standard answer. Best wishes.