Imo the FDA is prioritising batch consistency over and above Childrens lives!
They are doing harm again in my opinion as if they had prioritised Children's Lives over batch consistency then Mesoblast would of been able to expanded into multiple Treatment Centres worldwide.
Now would a reasonable person considered the FDA actions fair and reasonable?
Might a high paid lawyer from a big pharmaceutical company brought the FDA's unreasonable action to the FDA's attention by now?
Ann: Mesoblast Update on COVID-19 ARDS Trial, page-1039
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