Complete the rolling BLA submission to the U.S. FDA for beti-cel
Delivered after the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 23 Feb 2021
- Due
- 30 Jun 2021
- Delivered
- September 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The company is on track to complete its rolling BLA submission to the U.S. FDA for beti-cel in mid-2021, contingent upon successful resolution of any U.S. FDA concerns”
What we found
Evidence strength A What the grades mean
bluebird bio said in July 2021 it was still on track for mid-2021 BLA completion; a November 2021 filing says the submission was completed in September 2021, after the June 30 deadline.
-
A bluebird bio, Inc. 8-K filed 2021-07-09
“bluebird bio is on track to complete its rolling Biologics License Application (BLA) submission to the FDA for beti-cel in mid-2021.” ✓ confirmed on the page
-
A bluebird bio, Inc. 10-Q filed 2021-11-05
“In September 2021, we completed the submission of our BLA to the FDA for beti-cel in adult, adolescent, and pediatric patients with β-thalassemia” ✓ confirmed on the page
Checked 26 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory other
- Indicative materiality
- Medium rules
- Action
- Complete
- Deliverable
- Rolling BLA submission to U.S. FDA for beti-cel
- Where
- United States
- Language
- Firm (“will”, “on track to”)
- In the company’s control
- Medium
- Specificity
- High
- Conditional
- Yes: contingent upon successful resolution of any U.S. FDA concerns from SCD safety events
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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