Submit pre-market approval application for Niyad
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
- 22 Jan 2024
- Due
- 31 Dec 2024
- Checked
- 22 Sep 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“with an expected pre-market approval (PMA) application submitted before the end of 2024”
What we found
Evidence strength B What the grades mean
Talphera did not submit the Niyad PMA application by end of 2024. By March 2025, they were targeting study completion in Q4 2025 instead.
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B Talphera Announces $26 Million Capital Commitment Original commitment: PMA application submitted before end of 2024
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B Talphera Announces Fourth Quarter and Full Year 2024 Financial Results March 2025 update: study expected to complete by end of 2025, no PMA submitted in 2024
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B Talphera Announces First Quarter 2024 Financial Results May 2024: revised guidance for September 30 topline data due to site activation delays
Checked 22 Sep 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
- Language
- Expected (“expects”, “plans”)
How this entry was checked
- Commitment recordedRecorded from the company's filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: disagreesGemini (Google) re-read the evidence blind and read it as “no_evidence”.
- 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
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Report an error in this entry Reference: KI-C-2024-TLPH-000054 · Corrections policy