Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-363

I wouldn't be surprised if we see an RMAT or breakthrough designation granted in 2021 for advanced CHF (LVAD already has RMAT), which would be a strong sign that the FDA is going to look into accelerated approval. My only hesitation is that I am not sure if the FDA will consider class II patients as 'life-threatening' conditions... class III most definitely would, but I'll need to do a little research to answer that.

And the more I think about it... a 60% reduction in MACE and mortality in class II patients ... that's going to be very hard for a big pharma in the cardiovascular space to ignore... seeing such a strong signal of clinical benefit in reduction in MACE and mortality... I feel the question is, which big pharma is going to sign-up as a partner in 2021.

Keeping in mind that this is a randomised controlled clinical trial and will definitely be 'adequate and controlled' trial data... so it's just a matter of whether or not it meets the rest of the accelerated approval criteria...