CBS in New York today - GvHD, page-6

Fear not col69... if you listen to around 10:56 mark in the latest investor presentation SI says there are meetings going on in next few months and the FDA submission for aGVHD will be "some time in the 1Q of 2019". Unlike many other clinical trials, MSB has over 2 years of clinical data from this product being administered in Japan so I believe the chances of a successful application are considerably higher than in normal circumstances. These discussions might also include  another US study for adult aGVHD which three times larger market which is also marketed by JCR in Japan .  The FDA will be conscious to protect off label abuse of a product not yet trialled in the US for the adult market when it is already being successfully prescribed  in Japan ! 

Just so we understand how close we all are to widespread commercialisation on several fronts....once a treatment has finished phase 3 trials and an application to the FDA is actually submitted..you are normally on to a home run. From the link below the success rate is calculated to be 80%. From my rudimentary understanding of those that fail post application ... new information emerges, often due to toxicity or susceptibility to infection or some other form of post filing adverse effect. The fact that aGVHD has been available now for so long makes you this highly unlikely in my opinion (rose tinted )

https://www.chemistryworld.com/news/fda-new-drug-approvals-more-than-doubled-in-2017/3008575.article