" FDA have explicitly laid out to MSB that, yes, off-label will...

" FDA have explicitly laid out to MSB that, yes, off-label will be a certainty"

FDA doesn't need to say anything regarding off label use.

Once we have approval for children, doctors may prescribe Remestemcel for adults without any further input from FDA.

As long as insurance companies and doctors are willing, we might see a lot of off label use in adults. But without FDA approval for adults, MSB may not advertise/market Remestemcel for use in adults - they can only respond to the demand that arises.

Getting FDA approval for adults could expand our market because we can then actively market our product for this use, and it might convince more insurance companies and doctors to give it a try.

And if that takes off, maybe they will go further and try off label use for chronic GVHD.