MSB to dispute FDA finding in Type A meeting, page-431

Re part B. Unfortunately I don't think that the FDA could grant a EUA without legislation change for aGVHD.

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

MSB have done their homework.
I believe that they may be planning a two pronged approach to the FDA'S type A meeting. Remember that the interim analysis of the ARDS trial is due early next month. That may well satisfy the FDA guide lines for unconditional approval for both ARDS and aGVHD . We would then have two successful P3 trials using remestemcell, one is the randomised controlled study that the FDA demand

The other competitors product got approved on this basis despite safty concerns.

All in my opinion, the stars are aligning in perfect formation. Good luck.