Another way to look at this is from the perspective of the FDA.
If the FDA didn't specifically question Mesoblast on this topic (given the history) then the FDA would be deemed incompetent (or worse, perhaps, corrupt? Or worse still....?).
Mesoblast has been doing multiple trials with the FDA over 11 years+ and this topic hasn't been discussed in detail and at length until now? I don't think so, personally.
The market is surprised that the FDA is asking Mesoblast detailed and pertinent questions regarding manufacturing before approval? And Mesoblast did a CR a few weeks ago with the main purpose of manufacturing capability (rather than JV with big pharma). Quite a coincidence.
MSB Trading - Aug 2020 on, page-903
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