Ann: Submits New Information to FDA IND File for SR-aGVHD, page-184

It's largely conjecture, but to throw another view out there I believe the pathway taken by Mesoblast (guided by the FDA) could be due to the fact that if they did a conventional BLA resubmission, it would in its current form, be rejected as an incomplete response, as what Mesoblast have submitted is only directly addressing two of the three key points raised in the CRL i.e. recommendation to conduct at least one other RCT in adults and/or children has not been directly addressed.

So before a BLA resubmission is formally made, the FDA/CBER/OTAT need to in essence retract the recommendation to conduct another RCT to bolster efficacy data.

And this pathway 'submit data to IND file' as opposed to a formal BLA resubmission may be the agreed approach between the parties.

So for instance, if OTAT raised the recommendation to run another RCT... then if they believe Mesoblast has addressed the other two points, then they will accept the submission as a BLA resubmission either starting the clock after it is resubmitted formally, or possibly the review clock has already begun (if the FDA determine this submission is a BLA resubmission after initial review).

But whatever the case, the wording used in the Annual Report due later this month will be interesting and if they still quote a potential approval in Q1 CY 2023, then I would interpret that to mean that for all intensive purposes, this submission to the IND file for Ryoncil is in substance a BLA resubmission.