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Wednesday, November 26, 2014 8:34:32 PM
Here's the thing: They can't design a phase 2/3 trial for a combination because they have to prove safety first which includes a new dose escalation and a new PK/PD for the drug in combination. Phase 2/3 can only be for a mono-therapy, period, which can only be approved if there is tumor shrinkage, lesion closing, AND pain relief. Emphasis on "and."
Bottom line here, all evidence points to 1) tumor shrinkage against at least on Cancer type, 2) at a much lower dosage than the mouse study conversion would have us believe, 3) in the case of K simple scaling conversion is indeed misleading, and 4) we will have all the answers in 6 months and those answers will be which tumor types and not if.
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