Yes, still far from certain
The translation is:
SI doesn't think further trial evidence for aGVHD is required
He may or may not have asked the FDA if this is the case
If he has, the FDA haven't exactly confirmed this.
At best they have said they will consider it.
Or more likely he simply thinks that the data dredging "generated" enough new information to satisfy the concerns pointed out by the FDA.
But the FDA haven't responded yet.
Yes, still far from certain The translation is: SI doesn't think...
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