Okay, actually, very pleased how it's worded. My take after doing a quick comparison. Revenue opportunity is now even more loaded upfront for Mesoblast!!
- this BLA's addressable market is expanded
- FDA has kept the PDUFA date loose, so they likely will
approve it much less than 6 months but given themselves the opportunity to take time in any case.
Market will keep speculating the path forward and approval date, which is good!!
Good luck to Mesoblast and true believers!!
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-62
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