In terms of "remaining issues" one may need to separate science from logistics (BLA). Here the clinical science is said to be right ... and the value is in clinical science. BLA etc will simply be a matter of "when" not if. And having covered most of the BLA work, the "when" is likely not in the distant future. But again, the value is now here, in the clinical science.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-177
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