Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-273

When asked about a potential further trial, Silvo states;

"Our discussions with the FDA have been, potentially meeting a mortality reduction outcome will suffice for a single trial approval in that patient population with a high mortality risk. Whilst mortality was a secondary end point and not a primary, achieving it in this order of magnitude is a very important observation that i think we will be sitting down with the FDA in close order.

Hospitalization, traditionally have been considered to be surrogate to primary end point as drugs that have been approved for Heart Failure have not been able to achieve Mortality outcomes.

I think our study suggests even more than that, It raises the possibility that heart failure hospitalisations may not even be appropriate surrogates for mortality since we've had such a strong mortality affect and i think that is what i mean when i say that this will potentially change the paradigm of how heart failure should be considered in terms of its treatment characteristics."

BULLISH!!