Have a read of the FDA release sent to MSB for the BLA. They're still seeking to understand exactly what it going on with MSB's MSCs. But since the treatment is for a high mortality condition with no good alternative for kids, they are okay with approving it. Not sure the same will fly with Revascor or Rem-L in other indications. But they're willing to accept limited or confounding data if the downside is low and the upside is quite good in conditions where there is no good alternative therapy.
So what's the alternative for patients with HR-aGvHD? There is none.
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