Great Work MSB. I am very relieved.
Why do I feel like the acceptance today of the resubmitted BLA which had to address the CRL items is the harder part and the FDA approval is now just an easier formality.
I guess as it’s taken years just to address the CRL items and that was long and hard, I believe the FDA already know REM-L works, it just had to be fully detailed and quantified why it does and how it is safe and consistent.
The approval seems easy from here.
Anyone else feel a bit like that?
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-281
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