Submit BLA resubmission with requested CMC information
Delivered after the deadline (28 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
- 22 Apr 2024
- Due
- 30 Sep 2024
- Delivered
- 28 Oct 2024
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“We anticipate completing the BLA resubmission in the third quarter of 2024 with necessary updates to fully satisfy all the deficiencies outlined in the CRL.”
What we found
Evidence strength A What the grades mean
The company committed to resubmitting the BLA in the third quarter of 2024, but the actual resubmission occurred on October 28, 2024, which is in the fourth quarter.
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A Abeona Therapeutics Inc. 10-Q filed 2024-11-14
“On August 8, 2024, we completed a Type A Meeting with the FDA to discuss our forthcoming resubmission of our BLA and on October 28, 2024, we resubmitted our BLA.” ✓ confirmed on the page
Market reaction: the shares moved -2.4% against the S&P 500 over the three sessions around the disclosure (13 Nov 2024 to 18 Nov 2024). 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
- BLA resubmission
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- 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-2024-ABEO-003397 · Corrections policy