MSB 1.01% $1.00 mesoblast limited

Ann: Submits New Information to FDA IND File for SR-aGVHD, page-6

  1. 12,358 Posts.
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    Classic MSB - albeit a little bit late, but always deliver on what they say they will do.
    So, I'm happy with this - as one part of the wait has been done!

    We are now embarking on our road to commercialisation and can have decent discussions with the fact that the Ryoncil BLA has been finally resubmitted.

    There are always risks associated with the FDA, but given the amount of time taken to resubmit; with all the i's have been dottend and the t's crossed - I'm very confident of an FDA approval.

    Bring on the PDUFA date and get the FDA ticking biggrin.png

    GL MSB'ers
 
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