Hi @otherperspective
thanks for the kind words & here's wishing a very Happy New Year to all MSB holders.
It's crazy to think that all that's obviously standing between a flying head start to Mesoblast Ltd's commercial operations (stock in place, payers teed up etc) is a degree of variability in MSB's cell-based assays as they were implemented during GVHD-001.
I'm hoping someone at Mesoblast has already rung up the supplier & asked "Hey, what's wrong with the assay kit I bought?" - just kidding, of course. I'm aware that CEO Itescu has clarified that it's taken almost a year and a half for MSB (presumably together with Lonza) to track down the source of variability in the problematic reagent that was affecting assay consistency. And that it's been addressed.
But IMO it's reasonable to then think about everything that can go wrong in biotech, generally. I can only count our blessings that Mesoblast has managed to keep going when others have failed in trying times despite being close to the line - Athersys Inc. being a recent & very sad example.
Cheers all
See you in the New Year
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