Apply for FDA Emergency Use Authorization and EMA Conditional Marketing Authorisation for Sarconeos
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
- 26 Feb 2021
- Due
- 30 Jun 2021
- Checked
- 26 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“the Company anticipates applying for Emergency Use Authorization from FDA, and Conditional Market Approval from EMA in Q2 2021”
What we found
Evidence strength A What the grades mean
The July 1, 2021 6-K moved the expected EUA/CMA filings from Q2 2021 to by year-end 2021; no filing was reported as made by the deadline.
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A Biophytis S.A. 6-K filed 2021-07-01
“Top line results for the full study are now expected in Q4 2021, in view of a potential filing for Emergency Use Authorization and Conditional market Approval applications respectively with FDA and EMA by year end.” ✓ confirmed on the page
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A Biophytis S.A. 6-K filed 2021-07-01
“These contracts were signed in preparation of the potential filing of the product in COVID-19 for Emergency Use Authorization with FDA, or Conditional Marketing Authorization with EMA.” ✓ confirmed on the page
Checked 26 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
- Apply
- Deliverable
- FDA Emergency Use Authorization and EMA conditional approval applications
- Where
- United States and European Union
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- Medium
- Conditional
- Yes: subject to any COVID-19 related delays
- 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, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2021-C768946-024743 · Corrections policy