The ARDS is on hold until the potency assay for GvHD is accepted. Potency assay will not be accepted until PDUFA date ( once they have fully reviewed the efficacy / outcomes vs the assay).
A few people thought it could happen earlier, but only a full review of the assay and supporting data, is going to confirm if the assay is acceptable.
So date on that should be by July 31st if FDA honor the priority review status.
Over the next 5 months.... quite a lot happening!
2023 The Final Countdown, page-51
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