@Beno77 yes,it will be easier in the sense that the fda have...

@Beno77 yes,
it will be easier in the sense that the fda have previous clinical trials to prove that there aren’t any safety concerns and that the upcoming approval will mean they have already addressed any manufacturing concerns in terms of batch consistency and what their plan is in regards to testing/maintaining this etc and will then be able to issue label extensions promptly provided that it has proven efficacy in whatever indication it is attempting to treat. My understanding is that mesoblast is in active discussions following the ODAC meeting with the fda in regards to how best accomodate any concerns the fda has, hence why I think there hasnt been any early update for approval as it will be a complex process to arrange