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Friday, August 16, 2019 8:22:27 AM
Meaning that the stats only include those that had shown an 'objective response' to Nivo by the six-month landmark point.
Pooled ORR over the four studies is 30% at best, though they do not even cite the figure. So it discounts the 70% who never responded in the first place (or responded with hyperprogression).
So when they state that 4yr survival is a pooled 14%, they are referring to 14% of 30%, or about 5%...
And the 'Long-term data did not show any new safety signals' takes the biscuit.
They should refer to it as toxicity signals, not safety signals. And the gamut of toxicities associated with ICI's is very wide indeed.
This bar is so close to the ground, that Direct should simply step over it.
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