The FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD," the company said.
It says it there,
Conduct at LEAST ONE addiditional randomized, controlled study in adults and or children,
This will probably take less than 30 days.
With the ODAC Decision 9 to 1,
It says there
This vote includes a change to the original vote by one of the ODAC panel members after electronic
voting closed.
So from 9 to 1 .. it became 8 to 2.
Which is why they asked for at LEAST ONE additional randomized/controlled study in adults or children.
IMHO !
What planet are the FDA on, page-51
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