Submit a Type II variation regulatory filing to the EMA
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
- 11 Feb 2021
- Due
- 30 Apr 2021
- Delivered
- April 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Karyopharm also intends to submit a second regulatory filing to the EMA (Type II variation) based on the data from the confirmatory Phase 3 BOSTON study by April 2021.”
What we found
Evidence strength A What the grades mean
The company submitted and the EMA validated the Type II variation marketing authorization application in April 2021, meeting the commitment to submit the filing by the end of April 2021.
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A Karyopharm Therapeutics Inc. 8-K filed 2021-05-03
“In April 2021, the EMA validated Karyopharm’s Type II Variation Marketing Authorization Application for NEXPOVIO in combination with Velcade® and dexamethasone” ✓ 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 filing
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- Type II variation regulatory filing
- Where
- Europe
- 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.
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-2021-KPTI-023599 · Corrections policy