I missed this little gem.
Yes, SI did say "the committee voted 8-1 to approve Remestemcel"But they were only tasked with voting on whether they thought it might have "efficacy" based on the evidence presented. Which was fairly low quality evidence with quite a lot of deficiencies. And several of them saif they thought it was 50/50 but voted yes to give it the benefit of the doubt.Thats hardly convincing and the committee had no mandate or power to vote to "approve" it.
The FDA continues to approve remestemcel-L for emergency use because IT WORKS!
They're quite happy that MSB is not remunerated for saving the lives of children with aGVHD.
This is the marvellous FDA whom you imagine are always completely consistent, logical and ethical.
LOL!
Ann: Mesoblast Completes Institutional Allocation, page-199
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