No…
The CRL issue another poster pointed out to me was about CMC issues revolving around the potency of batch to batch matching if different donors were used and homogeneity between different donors with respect to different batches
Now according to SI in the 31 March quarterly update the potency assay was well understood and the FDA thought it was reasonable So we are hopefully resubmitting the BLA
https://cdn-api.markitdigital.com/a...access_token=83ff96335c2d45a094df02a206a39ff4
MSB $1 Party, page-473
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