CEO Itescu needs to go, page-223

@Phaedrus, Sorry, I'm not following the logic of going to the trouble of enrolling controls prospectively but not randomizing them... If patients are not randomized to a control group how would you ensure the study is blinded and unbiased? The gold standard is prospective, controlled, randomized and blinded. Anything short of that has the potential for bias and subsequent criticism by the FDA. Sounds like what you are proposing is an open-label study. And that may indeed be what SI hopes to have authorized at the Type A meeting. Sounds like it. But just because the FDA authorizes a study to be done doesn't mean it will necessarily accept the results in stand-alone fashion for approval of a BLA. Again, that's what got us in the current jam - taking shortcuts from the gold standard for conducting clinical trials. Especially important to respect the gold standard with a first-in-class product. SI's plan for the Type A meeting doesn't instill confidence... The prospect looms that Mesoblast may ultimately abandon GvHD and turn to indications where they have stronger data from an initial phase 3 trial that just needs a confirmatory trial.