Mesoblast CC Transcript 31/8, page-50

Hi all, I have a couple of questions but I appreciate responses with support of reported info not views, or at least views with supportive reason/evidence. Thanks.

1- Reflecting on SI's comments re link between ph 3 and current product; Does it mean FDA's concern centred on whether the product made/used for phase 3 trial was the same as the current commercially risk product? Is there, or how can we deduct an evidence of FDA's position on this (even from the CC)?

2- SI: "We also proposed providing FDA with new clinical trial data in adults, ..." Does this mean we will provided the with new-to-FDA data, i.e., data that has been gathered since what was presented to FDA (perhaps as part of BLA resubmission and/or well before the complete response?). Or is SI talking bout new data to be gathered with new trial (going by how he talks about cost reduction for funding)?