File for Emergency Use Authorization with the FDA for COVAXIN
Not delivered by 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
- 5 Feb 2021
- Due
- 30 Jun 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Planned EUA Filing with FDA”
What we found
Evidence strength A What the grades mean
The company did not file for an EUA for COVAXIN by the deadline, as the FDA recommended pursuing a Biologics License Application (BLA) instead.
-
A Ocugen, Inc. 10-Q filed 2021-08-06
“the FDA... recommended that the Company pursue a Biologics License Application ("BLA") submission instead of an Emergency Use Authorization ("EUA") application for COVAXIN in the United States.” ✓ confirmed on the page
-
A Ocugen, Inc. 10-Q filed 2021-08-06
“The FDA has recommended that we submit a BLA for COVAXIN rather than seeking an EUA as we originally had planned.” ✓ 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
- File
- Deliverable
- EUA filing for COVAXIN
- Where
- US
- 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- Second check: disagreesClaude (Anthropic) re-read the evidence blind and read it as “Superseded”.
- Tie-breakA stronger model read the evidence and both earlier answers, without knowing which was recorded, and agrees with the second check.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
Are you Ocugen, Inc.? You can publish an official statement next to this entry, free. Add a statement.
Is something here wrong or out of date? Companies and readers can ask us to check it. Please bring a link to a public source.
Report an error in this entry Reference: KI-C-2021-OCGN-023214 · Corrections policy