I think FDA must first accept the resubmission of the BLA, then they will inspect the Lonza mfg site.
Today, 3 different companies received CRLs, and the reason for Coherus receiving a CRL is due to inability of the FDA to inspect manufacturing site in China (due to covid lockdown)
The FDA is a tough nut isn't it. Do things their ways or the highway.
I think FDA must first accept the resubmission of the BLA, then...
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