Ann: Rexlemestrocel Greatest Benefit in Diabetics and Ischemics, page-7

to those who think MSB were grabbing at straws with the post trial analyses... the FDA was actually asking MSB to do the extra analyses in recognition of the amazing results, as to guide the approval pathway.

MSB have now done this as requested by the FDA, and will formally submit the final post trial analysis of the DRAM-HF phase 3 trial.


How did our cells compare to previously approved treatments for the 3-point MACE (stroke, heart attack and cardiac death)? From 12-14% to potentially 60-80% reduction over 5 years... that is what you call a paradigm shift.

And the key point...


Reading the above tells me one thing... MSB are going for an accelerated approval pathway for CHF... and it may be that the FDA have hinted of the possibility given the amazing results.

Note emphasis on FDA guidance stating when a "SINGLE" trial is sufficient for BLA submission ... that's right, when it shows clinically meaningful effect on mortality or prevention of disease when a second trial (could take another 5 years), would be practically or ethically impossible. So you do hold back on this treatment for 5 years, or just put it out there given the amazing results, and do a confirmatory trial post approval?

It becomes an ethical question for the FDA now... difference with SR-aGVHD is that the population of CHF patients is MASSIVE. And the 5 year wait on another trial, could be determining factors. Also totally different panel looking at CHF.

This alone justifies multiples of todays market cap... that's my opinion.

Goodluck all