It may be that my terminology 'enhanced mechanism of action' needs clarification. Mesoblast has never used the term 'enchanced mechanism of action', rather that is just how I distinguish between what Mesoblast proposed as their mechanism of action and CQA's in the first BLA vs what they plan to submit now.
So I see it as a whole package as I believe they need to be looked at collectively to understand what Mesoblast are trying to demonstrate.
My understanding is that Critical Quality Attributes (CQA's) are used to demonstrate the relationship between the proposed mechanism of action, quality and potency of the product.
So strictly speaking I am not suggesting the actual mechanism of action itself has changed, but rather Mesoblast's way of demonstrating to the FDA how the mechanism of action relates to quality, potency and ultimately patient outcomes is enhanced. Hence my term 'enhanced mechanism of action'. Otherwise, I'd have to type all that out each time I wanted to talk about it. But happy to take on a better term if you have a suggestion. And keen to get your views, as anything to better my understanding is always welcome.
(20min delay)