What are the stats on the product approval success following two CRLs
It's pretty high right?
Why are this percentage so high?
Because, if your product doesn't have a good chance of approval, you would give up on that product and move on rather than resubmit the BLA for the FDA to go through the approval process again.
Mesoblast obviously got some understanding and solid advice from the FDA; and therefore happy to resubmit the Ryoncil BLA for the 2nd time.
Bring it on!
GL MSB'ers - onwards and upwards
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