Device approval is a much, much lower bar as nothing is biologically administered that might cause adverse eventing. Almost all above ground creatures are exposed to low dose radiation every day so adding a little more within tolerable limits is no big deal for FDA. The Optune device stands to gain if proven to be synergistic with L but stands to lose big time if not. The Phase 3 study hinted that it might be synergistic at least in some cases. If so hurray. The question is does NVCR really want to put this to the test or do they think they have more to lose by doing so. Best wishes.
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