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RRRichmond

05/17/15 2:46 PM

#34862 RE: Doc x 4 #34861

This could only be tried in the U.S. if DCVAX we're to be designated a "first line" therapy. The FDA requires that the SOC be administered prior to any treatment that is in a trial. I believe that existing SOC, as currently administered, would likely hamper the patient's outcome if they were getting DCVAX after a post resection Hyperthermia treatment. From what I see, SOC (Radiation + Chemo) should be contraindicated with immunotherapy. The FDA has not reached that same conclusion. If DCVax survives it's present SOC required trial, we will someday get the chance to see what it does with less damaging adjuvants. I expect that would occur in Europe and be scheduled post 2022.