Hold a pre-NDA meeting with the FDA for stem-cell mobilization indication
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
- 23 Feb 2021
- Due
- 31 Dec 2021
- Delivered
- December 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“including a pre-NDA meeting with the FDA planned for the second half of 2021.”
What we found
Evidence strength A What the grades mean
The company held its pre-NDA meeting with the FDA in December 2021, within the second-half 2021 window, and the FDA agreed the data package was sufficient for an NDA.
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A BioLineRx Ltd. 6-K filed 2022-01-18
“BioLineRx Announces Successful Completion of Pre-NDA Meeting with FDA for Motixafortide for Stem Cell Mobilization in Multiple Myeloma Patients” ✓ confirmed on the page
-
A BioLineRx Ltd. 6-K filed 2022-03-16
“Following our very productive pre-NDA meeting with FDA that we completed in December, we are diligently working to submit the NDA” ✓ confirmed on the page
-
A BioLineRx Ltd. 20-F filed 2022-03-16
“In December 2021, we held a pre-NDA meeting with the FDA. The purpose of the meeting was to obtain agreement from the FDA on the content of the proposed NDA” ✓ confirmed on the page
Checked 26 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 other
- Indicative materiality
- Medium rules
- Action
- Hold
- Deliverable
- Pre-NDA meeting with FDA for SCM
- Where
- United States
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- Medium
- Specificity
- Medium
- Depends on
- Government
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), 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-BLRX-024232 · Corrections policy