Submit a New Drug Application for Tyvaso DPI 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
- 28 Jan 2021
- Due
- 30 Apr 2021
- Delivered
- April 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“United Therapeutics intends to submit a New Drug Application (NDA) to the FDA for Tyvaso DPI for indications covering PAH and pulmonary hypertension associated with interstitial lung disease in April 2021”
What we found
Evidence strength A What the grades mean
United Therapeutics submitted the New Drug Application for Tyvaso DPI to the FDA in April 2021, meeting their stated commitment.
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A United Therapeutics Corp 10-Q filed 2021-05-05
“NDA submitted to the FDA April 2021” ✓ confirmed on the page
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A United Therapeutics Corp 8-K filed 2021-05-05
“In April 2021, we submitted an NDA for Tyvaso DPI for pulmonary arterial hypertension (PAH) and PH-ILD indications.” ✓ confirmed on the page
Market reaction: the shares moved -1.5% against the S&P 500 over the three sessions around the disclosure (4 May 2021 to 7 May 2021). What this measures
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 submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- Tyvaso DPI New Drug Application
- Language
- Aspirational (“aims”, “intends”)
- 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-UTHR-022553 · Corrections policy