banter and General Discussion, page-11430

IMO the senior consultants at the FDA who will review all the evidence of the BLA for the third time will want to see that all the claims being made by SI and MSB surrounding the potency assay and the "improved potency because of a different manufacturer" can be supported by high quality evidence from a randomized controlled clinical trial (not a small open label single arm trial with controls improperly derived from a database years after the original trial was completed). There isn't any good reason that an adult clinical trial can't be designed that compares the outcome of best treatment such as Ruxolutinib against Remsestemcel in a blinded controlled clinical trial. That's likely what the FDA would like to see.