"I assume you mean, to include 'to-date' or something...

"I assume you mean, to include 'to-date' or something similar."

No, I did not. Mesoblast is seeking to extend Ryoncil into adults, however not at the same second-line therapy position as paediatrics, but instead as a third-line therapy. You must look at this decision on face value and find it bizarre.

The only reason they want to do this is because if it was proposed as a therapy once a patient is steroid-refractory, it would be head-to-head with Ruxolitinib. Therefore, the only way to demonstrate efficacy would be to run a randomised, blinded trial. However, if they opt to be a third-line therapy, that caveat can be avoided and a single arm trial may be sufficient. This is FDA guidance, not my opinion: https://www.fda.gov/media/172524/download




So mesoblast would rather markedly limit their TAM to avoid running a randomised, blinded and ultimately well-controlled clinical trial. This tells you everything.