The ODAC vote was concerned with efficacy NOT "approval" and the minutes revealed a numbeer of the experts weren't particularly convinced but voted yes on te basis that there were few safety concerns.
They don't have a collegial relationship with the FDA. The second CRL shows that was false.
The point about the labelling is that it shows the misplaced confifence SI had that the treatment would be approved. And he intended that shareholders should receive that interpretation.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-650
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