Submit the marketing approval dossier for the BF-RhodoLED® XL lamp 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
- 31 Mar 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“we expect the dossier for marketing approval to be submitted to the FDA in the first quarter of 2021.”
What we found
Evidence strength A What the grades mean
Biofrontera announced on March 31, 2021, that it had submitted the application for FDA approval of the BF-RhodoLED® XL lamp, meeting the first-quarter deadline.
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A Biofrontera AG 6-K filed 2021-03-31
“Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, today announced the submission for approval of a new, significantly larger red-light source for photodynamic therapy (PDT) to be used in combination with Ameluz®, the BF-RhodoLED” ✓ 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 filing
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- Marketing approval dossier
- 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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