Submit BLA filing for EB-101
Delivered after the deadline (178 days after the deadline)
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 15 Nov 2021
- Due
- 31 Mar 2023
- Delivered
- 25 Sep 2023
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“BLA filing anticipated in late-2022 to early-2023”
What we found
Evidence strength A What the grades mean
The company missed its early-2023 deadline, ultimately submitting the BLA for EB-101 on September 25, 2023.
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A Abeona Therapeutics Inc. 10-Q filed 2023-11-13
“On September 25, 2023, we submitted a Biologics License Application (“BLA”) for EB-101 to the U.S. Food and Drug Administration (“FDA”).” ✓ confirmed on the page
Market reaction: the shares moved -0.6% against the S&P 500 over the three sessions around the disclosure (10 Nov 2023 to 15 Nov 2023). What this measures
Checked 2 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 submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- EB-101 BLA filing
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- Medium
- 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, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Claude (Anthropic), re-read the evidence without being told the outcome and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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Report an error in this entry Reference: KI-C-2021-ABEO-003380 · Corrections policy