The only thing that concerns me for CHF, is the companies proposal for sub group analysis that the FDA has asked for.
For example. without any sub group , 3 point mace reduced by 33%..... they then used ischemics or diabetics and that reduced to 37%.........
not really much of a change, but that subgroup represents over 50% of the original intent to treat group. So it looks like they are trying to keep their patient population as broad as possible... but the problem with that is lower efficacy is demonstrated.... Don't get me wrong, 37 % reduction in 3 point mace is unheard of..... but so is 50% or 80%., and I thought that over 50% of the patient population were inflamed?
But then on the next slide the truth is revealed...... if you are not inflamed, the cells do not help.
With inflamed diabetics/ischemics, it had over 50% reduction, and inflamed class 2 was over an 80% reduction....
It seems that the company now is trying to manoeuvre for and approval in the diabetic / ischemic category, instead of in the class 2 or class 3 heart failure category. It would make more sense to me if it were in the heart failure category, and you must have inflammation present? That is where all of the evidence is pointing
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