Investigation of Mesoblast Limited (MESO) on Behalf of Investors, page-53

It almost comes back to figuring out the correct dose to give. They calculated the dose based on response, but at that stage the TNFR1 levels were less. Now we did get a good response but with higher levels. From that point of view, the biomarkers must be valid.

The data from the last phase 3 trial is what it is . It showed around a 70 % response rate which is higher than typically observed according to Kurtzburg who was the lead investigator, placebo are or not. The FDA seems to have completely overlooked this point , and discredited the methods used to generate the null hypothesis and the stats as a result.

Could the company provide more data to come up with an acceptable null hypothesis, acceptable stats ?
Sounds like FDA are unwilling to accept this idea at all no matter how realistic it is- hence the Trial request.