Please improve your language comprehension skills.
That is a conditional statement.
Efficacy not considered unless a suitable potency assay is provided at the same time.
MSB in the process of getting that assay to submit and then efficacy within that trial can be considered by the FDA.
If it is not comprehension skills ( the poor patients or are you in fact just a janitor ) then it is an intention to mislead.
Ann: Mesoblast Type A Meeting with FDA, page-389
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