These results are simply amazing. One wonders how the FDA could ignore this latest data (but who knows).
This is Long-term evidence of survival of children treated with remestemcel-L, through 4 years. Four years !!!
Overall survival at 2 years was 51% in remestemcel-L treated children, as opposed to just 25-38% if they received best available therapy(BAT)
In the words of the company ... "These long-term survival outcomes are a key component of the Biologics License Application(BLA) resubmission to the United States Food and Drug Administration (FDA)" So now we know.
Finally we should see 'daylight' with the FDA. These data speak for themselves.
Opinion only of course.
These results are simply amazing. One wonders how the FDA could...
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