That fits nicely with the H12023 approval period
Mesoblast has comb through and answered all the CRL questions
Got ODAC 9-1 vote
Got long term data as insurance
What else does the FDA need?
Ryoncil approval will certainly change the dynamics of this company - we are on our way to commercialisation - finally!!!
Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel, page-20
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