Yeah. Makes perfect sense. They asked us for that data for a reason. The group that did the best was inflamed diabetic and/or ishemic CHF patients. It may also help that this is a very tightly defined group (i.e. simple cut of levels for inflammation and diabetes, so you are either eligible or not - no guesswork; ECG for cardiac ishemia). I assume if AA is given to this defined group then the Phase IV Confirmatory Trial will also be limited to this group. FANTASTIC!
If this is the case, in the real world you may be a bit cheesed off if you were an inflamed non-ishemic NYHA Class II without diabetes that falls outside the eligibility criteria - as we saw excellent results in all Class II patients. I suppose they would be ideal candidates for off-label usage though...
OK, calm for now until the FDA advise.
Yeah. Makes perfect sense. They asked us for that data for a...
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