Monday, September 13, 2021 2:29:46 PM
That was a change to the primary endpoint made on July 22nd. That is not a change to inclusion/exclusion criteria. If their aim was to exclude CRP > 150 they would have done so then but it still hasn't been changed. The only change to inclusion/exclusion criteria made at the time is those who have used prednisone in the last 7 days are not excluded. Also ordinal scale category 5, 6, or 7 is now referred to as ordinal score 5, 6, or 7.
For eligibility there is no longer any maximum age which had been set to 99. If lenzilumab has a hard time saving the lives of those 85+ just imagine the struggle with centenarians.
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