We've been over this already - there is a big misunderstanding here that the accelerated approval means the heart failure indication will be commercialised soon - this is not the case. Again IMO.
The evidence is not there - they failed the first study, found some interesting potential areas to investigate further, and have now discussed the potential for accelerated approval - meaning approval based on a surrogate endpoint for a future study. They won't do this retrospectively, that's not how it works.
So that is still years and many cap raises away.
A lot of this is absolutely hype. This is a billion dollar company bleeding money left and right and continue to fail to prove their products work.
Maybe third times the charm
imo.
good luck
I hope I'm wrong
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-131
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