Pick Today's Price Range Low-High... Just for Fun, page-467

If accelerated approval is granted our product will be on market full-stop for the indication granted (e.g. LVAD, ischaemics/diabetics). Yes a further trial is required to receive full approval which will determine if the product stays on the market with it's current indication. If confirmatory trial evidence supports indication then 'stays on market', if trial evidence does not support indication given accelerated approval then 'indication modified or product removed from the market'. Like others have pointed out another trial will be necessary if it is granted accelerated approval but it is what is known as a Phase IV trial (confirmatory trial). This will be run while the product is on the market if FDA grant accelerated approval. I think the outcome of this meeting which has accelerated approval on the cards is the catalyst that will trigger a partnership for heart (and in what form depending on the outcome).