CLBP has nothing to do with Remestemcel-L potency assays … Rexlemestrocel-L used to treat both CHF and CLBP is a different product altogether and ‘technically’ potency assays for Rex-L were agreed upon years ago prior to the large CHF phase 3 trial as referenced in the below post …
https://hotcopper.com.au/threads/an...6848659/page-83?post_id=62611150#.Yz009C3ZWhA
Ann: Submits New Information to FDA IND File for SR-aGVHD, page-295
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