And yet somehow the potency assay and the efficacy are linked aren't they.
Try to work out how the potency assay matters to efficacy.
After all, there was SI telling everyone that the FDA said they couldn'y do another trial until they had a validated potency assay. Now he says although the FDA acknowledged that the potency assay had been "improved" it appears that the FDA don't seem to agree it's been validated. Yet 6 months ago SI was telling everyone they had a "validated potency assay" to submit as part of the BLA.
Some things that SI claims don't seem to "align" with the FDA...
Ann: Mesoblast Type A Meeting with FDA, page-134
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