Global Blood Therapeutics, Inc.
Submit a New Drug Application for a pediatric formulation of Oxbryta
Delivered after 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
- 4 Feb 2021
- Due
- 30 Jun 2021
- Delivered
- July 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“GBT previously announced plans to submit a New Drug Application (NDA) for a pediatric formulation of Oxbryta for the treatment of SCD in children ages 4 to 11 years by mid-2021.”
What we found
Evidence strength A What the grades mean
The company submitted the required New Drug Application for the pediatric formulation in July 2021, which occurred after the mid-2021 deadline.
-
A Global Blood Therapeutics, Inc. 8-K filed 2021-08-03
“In July 2021, announced submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for Oxbryta for the treatment of SCD in children ages 4 to 11 years, together with a related separate NDA required to seek approval for a pedia” ✓ confirmed on the page
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
- New Drug Application for pediatric Oxbryta
- 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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