Submit the final study report for the Ameluz® pharmacokinetics study to the FDA
Delivered by 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
- 8 Feb 2021
- Due
- 31 Mar 2021
- Delivered
- February 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“We expect to submit the final study report to the U.S. Food and Drug Administration, or FDA, during the first quarter of 2021.”
What we found
Evidence strength A What the grades mean
The company submitted the final study report for the Ameluz® pharmacokinetics study to the FDA in February 2021, which is within the first quarter of 2021.
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A Biofrontera AG 20-F filed 2021-04-12
“The study report was submitted to the FDA in February 2021 with the objective of removing a restriction in the product information to the use of only one tube per treatment.” ✓ confirmed on the page
Checked 25 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
- Submit
- Deliverable
- Final study report
- Where
- United States
- 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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