In that case, I'm thankful it's your money they're spending, not mine!
What I'm saying is that the data that we have seen would not support a GI bleeding indication - and that even if FDA approved it no-one will pay for an expensive treatment that does not save any money! That is what the data says.
Of course, if you can pre-identify those who are going to have a GI bleed, then it could be a goer - because in that sub-group there is reduced hospitalisation.
And BTW - the FDA did not say that GI bleeding was an approvable indication - in MSB's words they said it "could meet requirements for an approvable regulatory endpoint". There is a vast difference.
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