MSB 0.54% 93.0¢ mesoblast limited

Ann: Trading Halt, page-410

  1. 3,268 Posts.
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    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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