Cell Therapy News/Articles, page-17948

I don't think you are looking at historical view properly with the appropriate related events, try to go in historical order - that would help

Original Ryoncil BLA submission:

• ODAC efficacy vote 9-1 for approval
• FDA CRL1 suggested trial for more evidence

1st Resubmission:

• FDA accepted that suggested trial was not required, and hence accepted the BLA resubmission
• Inspected and ticked off manufacturing
• FDA CRL2 requested for data for remaining CMC items

2nd Resubmission:

• FDA accepted resubmission - therefore, CRL2 items have been addressed
• Hence, something has changed the FDA view. New interpretation of data or new data itself perhaps?