Are the "other outstanding items" you mention a reference to this last sentence in the recent ann?
"Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining product characterization issues."
If so I believe "characterization" is a reference to the assay matrix queries from FDA.
The question is why not be specific instead of calling it "clinical data" earlier in the ann given efficacy wasn't an issue, if indeed as I believe they mean assayed samples when they referenced "clinical data".
Cheers.
2024 Here we go again., page-397
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