Submit NDA in Japan for somatrogon
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
- 13 Jan 2021
- Due
- 30 Jun 2021
- Delivered
- Q1 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“NDA submission in Japan anticipated 1H 2021”
What we found
Evidence strength A What the grades mean
Opko Health confirmed that regulatory submissions for somatrogon in Japan were accepted during the first quarter of 2021, meeting the commitment to submit the application by the first half of 2021.
-
A Opko Health, Inc. 10-Q filed 2021-07-29
“During the first quarter of 2021, regulatory submissions in the major global markets for Somatrogan have been accepted including, the U.S., European Medicines Agency, and Ministry of Health, Labour, and Welfare in Japan” ✓ confirmed on the page
Market reaction: the shares moved -8.5% against the S&P 500 over the three sessions around the disclosure (28 Jul 2021 to 2 Aug 2021). 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 submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- NDA submission
- Where
- Japan
- 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-OPK-021966 · Corrections policy