Submit a Special Protocol Assessment to the FDA for the Phase III trial in Hidradenitis Suppurativa
Delivered by the deadline
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- Announced
- 11 Jan 2021
- Due
- 31 Mar 2021
- Delivered
- March 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“InflaRx plans to submit a Special Protocol Assessment (SPA) to the Food & Drug Administration (FDA) for the Phase III trial in Hidradenitis Suppurativa in the first quarter of 2021.”
What we found
Evidence strength A What the grades mean
The company submitted the Special Protocol Assessment to the FDA in March 2021, which falls within the first quarter of 2021.
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A InflaRx N.V. 20-F filed 2022-03-24
“In March 2021, we submitted a Special Protocol Assessment (SPA) to the FDA for the Phase III HS program for vilobelimab in Hidradenitis Suppurativa (HS)” ✓ confirmed on the page
Market reaction: the shares moved -2.7% against the S&P 500 over the three sessions around the disclosure (23 Mar 2022 to 28 Mar 2022). What this measures
Checked 24 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
- SPA submission for HS Phase III trial
- 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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Report an error in this entry Reference: KI-C-2021-IFRX-021483 · Corrections policy