Ann: Mesoblast Type A Meeting with FDA, page-88

It shouldn't be difficult for Mesoblast to prove that each of their therapies meets a required specification tolerance when they are manufactured. This is bread and butter for all manufacturers, not just pharma or biotech. The fact that Mesoblast haven't given even sufficient proof by now, or shown beyond a doubt, all therapies produced meet a required specification tolerance does make me wonder what checks and balances they have in their manufacturing process. Sampling results based on predefined specifications are a cornerstone to manufacturing processes. This really shouldn't be a stumbling block. It is also a fair request from the FDA. Why does the Mesoblast need a bullet point stating they intend to generate in the coming months new potency assay data. This is the part of the presentation that should be bulletproof by now.