CEO Itescu needs to go, page-30

I think Mesoblast were told by the FDA that they would need "substantial new information" for any change in outcome of the BLA and that the CBER would review the information in totality. At no stage was the recommendation for a randomized trial withdrawn. Somehow SI and perhaps Dr Krause decided that it had been withdrawn, and clearly Mesoblast led John Hester and perhaps other brokers who had been supporting the company to believe that it was the case when in fact it wasn't. Perhaps SI has particular views and hopes and it was he who said at the FDA meeting that if they supplied new data then there would be no need for an RCT. Perhaps he got a reponse "maybe" or "we'll look at what you give us" and he took that as a "yes" when he shouldn't have. Clearly he persuaded himself that something was true when it wasn't.