https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label

The above excerpt from FDA - in 2018 - would assume still current though.

So assuming we get Rem-L over the line for paediatric SR-aGvHD. Then IMO 'off label use' may potentially include, assuming current treatments have failed (and also as stand alone therapy or add on's in emergency situations):
* Adult SR-aGvHD
* ARDS (Covid and non-Covid)
* Sepsis
* UC and Crohns etc

It seems 'off label' can be used for different indications, for different routes (e.g. both IV infusion and local injection), and in different dosages to that approved for aGvHD. In theory, very large potential - however in practice largely comes down to how much hospitals/doctors are familiar with product, whether insurance will foot the bill, family consent etc etc.

Our strong point is that Rem-L has an excellent safety profile, and not all patients respond to current small molecule treatments, so IMO there is real scope for 'off label' use; but let's not kid ourselves, the real money will follow once we have full FDA approval for these indications, and I remain positive that we will sooner or later.