That's my primary question right now also. Ok, there's some nice benefit in a certain sector of the patient population. But if it can't be determined who will benefit from MK until after surgery, but it needs to be administered before surgery, that means the logical conclusion is all patients should get MK.
But that's too simplistic, since it only helps 40% of the total population. If it helps the chemo group as well, but not as much... where is that data and why won't the CEO tell us? Why is he completely clammed up after the data drop? I thought he liked to fight for what he believes in? Positive data drops and he shrinks away?
Back to the MK administration, will the FDA throw this out b/c it can't be determined until after surgery who should get MK prior to surgery? A fatal logic circle? To me, this means a new more refined study (P4?) is called-for so that something can be pre-determined. It's not what I want, because I'm tired of waiting for the rubber to hit the road.
Unless they didn't miss the 10% OSI endpoint in the chemo group by a whole lot? What was it for the chemo group? If they hit 5% for the chemo group, then that could change the whole story and the FDA would be compelled to approve this no matter what? Again, WHY won't they tell us? WHY? They've got the data; we shouldn't have to ask this question.
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