I can’t wipe the smile off my face - this is fantastic news!
Yes, it’s still a long way to go, but this is significant and will drive our turnaround
Can someone remind me the success % of the third BLA, after receiving two CRLs?
It’s very high, as companies won’t be resubmitting if they believe their chance of approval is low.
After two CRLs, MSB must be triple checking everything before even considering the BLA resubmission. That first step was done recently.
MSB to FDA - with the new data, have we cleared all the CRL items?
Only with a definite YES would Mesoblast spend time & effort into the Ryoncil BLA resubmission… and that’s what we have here today.
The next step is product approval baby!
Bring it on
GL MSB’ers - onwards & upwards!
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