MSB 2.29% $1.07 mesoblast limited

Read what they said........ You've got enough ( Clinical data )...

  1. 4,124 Posts.
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    Read what they said........ You've got enough ( Clinical data ) - to get approved.

    It does not mean they will get approved, just that the clinical data is sufficient to argure the clinical data side of the case. They still need to comply with lebel requirements, shelf life and all the other non clinical data related requirements of a BLA to actually get approved.

    This just really means no extra trial required....... Does not mean CRL impossible.
 
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