Ann: Mesoblast Type A Meeting with FDA, page-34

This is how I read it.

The key to getting the potency assay validated is a successful randomized controlled clinical trial in adults with biomarker evidence that correlates with the Mechanism of Action and the potency assay. Investors here don't seem to have grasped the concept that that is how the FDA will agree the potency assay has been properly "validated" instead of "improved".

SI is still resisting the idea of doing a randomized and properly controlled clinical trial probably because he's afraid it could fail to show efficay which would completely doom Remestemcel and the company. So he has once again proposed a single arm trial that he thinks stacks the odds more favourably and the FDA have given a luke warm response that they will "consider it" at another meeting. But clearly it's not what they want. What they want to see is the whole box and dice sorted out in one properly designed and executed trial.