Mesoblast CC Transcript 31/8, page-40

It pays to be circumspect until after the Type A meeting. This meeting is basically an attempt for MSB to position themselves for one more play to get the ball into the end zone, but right now the situation at MSB headquarters is dire. At most, MSB need the FDA to agree on a open-label trial, which I think they will. MSB will then be able to raise funds on the back of this to see the trial through to completion. The trial could take around 12-14 months to achieve it's primary and key secondaries, but what happens if there's early signs of extraordinary efficacy? Given the FDA will receive the data as and when MSB receive it, do the FDA approve on the spot? or will they require resubmission of the NDA? If SI is the maestro that most believe he is, then he will make a play that will prevent MSB from having to resubmit the NDA.

My views, dyor