I don't think the issue was ever with effectiveness. The ODAC 9-1 vote is testiment to this.
The FDA concern was always with the MOA and manufacturing.
This latest data is however included to provide the FDA with additional assurance on top of already excellent phase 3 efficacy data, a 9-1 ODAC vote and now a couple investigational studies (one with matched MAGIC cohort patients, and now this new long term study).. that Ryoncil is effective.
Mar23-May23 is most likely IMO for potential Ryoncil approval.
Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel, page-17
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