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Thursday, January 24, 2019 5:19:16 PM
I have the impression that Linda Powers was not worried about the first endpoint (PFS) at the time.
May 7 – 2015 Linda Powers:
So four months difference is all we have to show in the phase three trial, and if we show that much of a difference, we will have a very strong p-value of .02. The trial is also powered for the secondary endpoint of overall survival, and as you see here, multiple subgroup analyses were prospectively included. There are a number of subgroups, certainly MGMT status is one of them; there are several others. In fact, MGMT status, which is a gene that effects chemo therapy sensitivity… that’s part of standard of care… to the chemotherapy, is included in the actual randomization of the patients. So it’s taken into account in the formula under which patients are randomized. So they’re even randomized for these factors. Again, that trial is due to finish around the summer of next year to reach the primary endpoint, and we are certainly looking forward to that.
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