Let me clarify

The amount of crap that is spoken on HotCopper is mind blowing.  Let me clarify!

As per my discussion with Cardiologist - I'll do my best some of it was very technical:

1.  The primary end point of temporary weaning (taking them of the heart pump for a little while)  was not achieved, overall, because pump thrombosis reduced the number of wean attempts.  NOTHING TO DO WITH MSB CELLS!!!!.  NOTE this was NIH continuation of the original end point, not FDA's focus!

2.  FDA focus was on GI Bleeding, why because reduction in bleeding results in reduction in hospitalisation and as a consequence significant reduction on cost.  And as is stipulated in the announcement this is what the FDA is focused on.  

"Under the RMAT designation, Mesoblast received specific guidance from the FDA that reduction in major GI bleeding episodes and related hospitalizations in the current trial is a clinically meaningful outcome with a high unmet need that could meet requirements for an approvable regulatory endpoint. In contrast, the FDA advised that the primary endpoint in the current trial of temporary weaning from full LVAD support is considered a biomarker and is not a clinically meaningful outcome in and of itself."

3. This trial v Phase CHF  are very different trials, LVAD trial does not give any insight into potential results of Phase 3 CHF.   This trial was focussed on reduction in bleeding for the FDA.  Phase 3 end points is reduction in Hospitalisation and Mortality rates