...remember, one of the things the FDA will have to chew on in a RYONCIL approval letter is whether to inspect lots after approval. Takes up time, requires (some) effort & costs money. Another 'belts and braces' type assay post-thaw would make it a little easier for them, I suggest, to forgo lot inspection as a condition of approval.
Just whistling in the wind.
Cheers all
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-973
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