"FDA’s position is that the product attributes the Applicant has...

"FDA’s position is that the product attributes the Applicant has identified as related to potency and activity, however, do not have a demonstrated relationship to the clinical performance of specific DP lots, and that the product’s proposed immunomodulatory mechanism of action has not been demonstrated in vivo in study subjects receiving remestemcel-L. Without a demonstrated relationship with clinical effectiveness and/or in vivo potency/activity, controlling these CQAs may not be sufficient to ensure the manufacturing process consistently produces remestemcel-L lots of acceptable quality. "

"Although these assays are consistent with the hypothesized mechanism of action of immunomodulatory activity, this mechanism of action has not been demonstrated in the clinical BLA 125706 ODAC Briefing DocumentRemestemcel-L: CMC7 trials submitted to support licensure"

"any efficacy remestemcel-L might have in treating this disease is not sufficient to demonstrate the product’s mechanism of action"

"A relationship between these in vitro lot release assays and the clinical effectiveness of the product has also not been demonstrated."

"FDA’s position is that while the CQAs identified by the Applicant and controlled in the product by in vitro lot release assays may have some value in assuring a consistent manufacturing process, these CQAs do not have a demonstrated relationship with clinical potency, and may therefore not by themselves ensure adequate control of clinical effectiveness of individual lots of product."

isn't this a bit negative?
sorry, not trying to downramp, just trying to understand and work out what might happen today!