Yes I have seen that statment. Have you looked at the regulation that was also mentioned?
They also add in that statment "for a marketing approval"
So taking this statment on board together with no mention of efficacy and aknowledgement of improvements in the assay, effecacy has been aknowledged but it is not in a way that they deem leagal for approval due to the regulation.
Ann: Mesoblast Type A Meeting with FDA, page-399
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