CYP Price Target post MSB FDA approval., page-154

This is a risk to patient recruitment in the US. Without a doubt, there is no way a patient would be eligible in the MSB trial if they're already a part of the Cynata trial.

Fortunately 21 of the 29 locations Cynata are recruiting High Risk aGvHD patients from are located outside the USA.

I think it would be fascinating to know what happens behind closed doors in those meetings with the BMT CTN and Mesoblast. On the one hand, you have a therapy who's prequel drug failed to demonstrate efficacy in adults. Also, it is intended to be used as a THIRD-LINE treatment, after patients have failed to respond to both steroids and Ruxolitinib. But it has paediatric approval from the FDA, so it has legitimacy and this will definitely assist the argument for directing patients to enter the MSB trial over CYP.

On the other hand, you have another, similar therapy (MSC's), except it's being trialled as a FIRST-LINE treatment, because the company thinks their more consistent product and different manufacturing approach results in a more potent and effective treatment. If it works, this is clearly better for everyone (patients, doctors, insurance co.'s, government etc.). But right now, there is no hard data available suggesting it works as a first-line treatment and the only way to generate this data is via clinical trials. A true catch-22.