Submit regulatory applications for Oleogel-S10 (Filsuvez) with authorities
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
- 4 Mar 2021
- Due
- 31 Mar 2021
- Delivered
- 30 Mar 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Regulatory submissions for Oleogel-S102 (Filsuvez®) on track for Q1 2021”
What we found
Evidence strength A What the grades mean
Later filings show the EMA application was submitted March 8, 2021 and the FDA NDA on March 30, 2021, both within Q1 2021. One filing gives March 31 for the NDA.
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A Amryt Pharma plc 20-F filed 2022-04-29
“An NDA was submitted to FDA on March 30, 2021, and a Marketing Authorization Application (“MMA”) was submitted to the EMA on March 8, 2021, with a procedure start date of March 25, 2021.” ✓ confirmed on the page
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A Amryt Pharma plc 20-F filed 2022-04-29
“As the final module in a Rolling Review a New Drug Application (NDA) was submitted to the FDA for Oloegel-S10 on March 31, 2021” ✓ confirmed on the page
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A Amryt Pharma plc 6-K filed 2021-05-05
“Regulatory submissions for Oleogel-S101 (Filsuvez®) made to the FDA and EMA” ✓ confirmed on the page
Checked 27 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
- Regulatory submissions for Oleogel-S10 (Filsuvez)
- In the company’s control
- High
- Specificity
- Medium
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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