Ann: Mesoblast Q3 Financial Results Webcast, page-139

we won’t know for sure what was in the CRL, but there are likely areas which the FDA may have clarified as being a critical point to address through the need of additional data... and others which the FDA agreed were acceptable given the situation.

If MSB were unable to make any inroads with the FDA in the past few months, they would have initiated the confirmatory trial already. The fact they are now looking to resubmit suggests they have an agreed pathway forward with the FDA that could lead to full approval, or still possibly accelerated approval, which if they want the new data to be considered, must firstly be done with a new NDA.

Its not a silver bullet, but it does suggest it could get approval within a year as opposed to 2 or 3