90% there quote from SI is your clue you have your head in the sand over.
Efficacy strongly suggested but no supported yet by sufficiently good potency data. SI thinks it is simply a matter of retesting the samples to get that data to meet the remaining 10%.
That is a lot cheaper and a lot quicker than what you desire given the 90% point has been reached.
Ann: Mesoblast Type A Meeting with FDA, page-459
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