Hi
They have had the Assay submission since October .
The FDA have proceeded to give RMAT for CLBP
Mesoblast have submitted the BLA months after the assays.
I dont think the Assays are a problem .
Its science and SI would not have announced they thought they had it right.
As far as the RCT who knows .
In essence the Assays are more important than GvHD but it will
throw a spanner in the works no doubt.
Getting exciting . $5.00 or 50c
Aloha.
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