You said: "So now instead of using the cells to prevent heart failure progression, we may be looking to cure strokes in diabetic patients with baseline levels of inflammation."
I disagree with that premise. Rex-L is still very much a therapy for preventing the progression of heart failure progression (at least from Stage II to Stage III) and I am sure this remains the focus of discussions with the FDA. The heart failure indication is still very much in play (and why wouldn't it be now that we have a chance at a single trial approval). What we are now presenting to the FDA is new data which highlights the largest patient groups that benefit the most in term of reduced Major Adverse Cardiac Events (an endpoint previously accepted by the FDA) in the heart failure patients.
The added benefit from Rex-L achieving a reasonable halt in progression of heart failure (that Standard of Care is unable to match) is a clinically meaningful and statistically significant reduction in heart attacks, strokes and cardiac death. Something the Standard of Care in Heart Failure Treatment is unable to match due to our unique Mode of Action.
So yes, we are progressing the indication for heart failure with the FDA as we speak; and like you say, but further down the track, we may decide to trial our cells for the early treatment of diabetes and/or prevention of strokes and heart attacks in patients without heart failure.
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