Very positive announcement. I think it is now time for a conference call. The announcement is a bit short on detail. Have we had the meeting or not ? The GVHD trial. Has the potency assay been approved.
What my takeaway is that the FDA is not just meeting there time frames but beating them and making decisions way faster than they could. This decision could have been left till the 30 days post meeting had lapsed.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-96
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