"Okay, how many clinical trials have been designed by Mesoblast that have failed? And then look for the subset of trials that have been run on aGVHD. Where is the failure? Or are you trying to bring Osiris back into the picture?"
I don't really want to dive into an argument about Mesoblast trial failures. I was referring to the widely reported Osiris trial failures, but only to make the point that Mesoblast needs to be careful about claiming the good parts of that (the safety record), but distancing itself from the bad (inconsistent and sometimes ineffective product). I believe strongly that Mesoblast has improved manufacturing processes and testing to ensure product consistency. Therefore the product now (remestemcel-L/Ryoncil) is different to then (Prochymal). By how much I don't know. Is it still right to claim over 1100 patients treated if the product isn't the same now?
I have confidence the FDA has a lot more information than we do, and they are perfectly capable of making the right decision. I expect to be celebrating soon (that's for approval in case anybody had doubts).
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