Straight from the US government (FDA).
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Objective Response Rate.
Generally, the FDA has defined ORR as thesum of partial responses plus complete responses. When defined in this manner, ORR is a direct measure of adrug antitumor activity, which can be evaluated in a single-arm study. Stable disease shouldnot be a component of ORR. Stable disease can reflect the natural history of disease, whereastumor reduction is a direct therapeutic effect.
So Raki and Pilbara let's not get personal and make assumptions about whether I hold or not. Let the science do that.
Straight from the US government (FDA). Clinical Trial Endpoints...
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