CRLs are not always the end of the world. They can highlight any deficiency in an application and could be a minor issue. There is a process to address CRLs and they do not always end in a withdraw of the application.
The FDA would not have been sitting on the backside for 30 days. I would figure that MSB has significant diaglog during the application. This would also include inspection of the manufacturing facilities at Lonza.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110
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