Thanks @Pharmagang - it’s still upset me that we have to now wait for OTAT.
Hopefully, this is the final procedural tick required!
As really, what has changed?
Ryoncil either work or not.
It’s either safe or not
All this procedural BS has just delayed this product approval to now more than 1 year - to what end does this serve?
Once approved, it’s the same product, same manufacturing, same screening process
Anyway - enough of a rant from me.
Here we are - Waiting for Mesoblast to present at OTAT & resume the BLA process
GL MSB’ers
Thanks @Pharmagang - it’s still upset me that we have to now...
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