@Bazsa. Agree. The FDA did request the data and MACE is an...

@Bazsa. Agree. The FDA did request the data and MACE is an approvable outcome. Phase IV confirmatory trial possible.

@DocMcstuffins - Totally disagree.
1. The procedure is minimally invasive and low-risk.
2. What's more the use of cardiac catheterisation is routinely performed by cardiologists worldwide (and the more serious but rare complications are further reduced because we are not targeting Class IV CHF patients).
3. I mean even a sham procedure received ethics approval for the DREAM trial so you can hardly say the FDA are worried about the method of delivering our cells.
4. The procedure went very well in the Dream trial, no significant issues.
5. The localised method of delivery (as opposed to an IV infusion) puts the cells right where they are most wanted in greater concentrations.
6. It seems the experts like Dr Perin would strongly disagree with you, and the many Cardiologists across the many treatment centres would also disagree, stem cell experts would also likely disagree, even patients and people on this forum would disagree.

It's just that obvious that the procedure is safe and effective in the inflamed patients we are targeting. Just because @DocMcstuffins have no idea how to do the procedure does not mean the FDA will need to reconsider the superior safety profile of the trial. Get real!