It’s really not that hard to understand…
The FDA supports the AA pathway, but the products itself will need to go through the arduous BLA process - and therefore the approval MAY be supported as the product approval is not guaranteed! Simples!
With ambulance chasers floating around, it’s prudent for Mesoblast to be cautious with their words
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-444
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