banter and General Discussion, page-579

The FDA is responsible for assessing all drugs/therapeutics if they are to be sold in the USA. This is similar to most international approaches, however each regulatory scheme has subtle differences.

As Ryoncil has gone through robust trials (in the USA: adds to credibility with that country's regulator), has demonstrated an ability to save many children's lives from aGVHD (for which there is no current treatment), and has been used successfully for years in Japan (as Temcell), is precisely the reason that it is on an expedited pathway with the FDA (Priority Review pathway).

More information about the significance of Priority Review here:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review

There is no certainty to anything in life (well, perhaps death and taxes...), but yes, I believe MSB has sufficient product data, staff knowledge and professional relationships with the FDA to point towards a successful review of Ryoncil.