Along with acceptance should come the new PDUFA action date as well ... a 2 month PDUFA action date would certainly grab the attention of the market and IMO is the only way that Remestemcel-L has any chance of being commercialised in Q1 CY 2023 ....
..... a 6 month PDUFA action date will certainly push commercialisation into Q2 CY 2023 assuming of course we receive approval in any of the scenarios outlined above
GLTAH
Ann: Submits New Information to FDA IND File for SR-aGVHD, page-29
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