Meet with the FDA to discuss accelerated approval for remestemcel-L
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
- 1 Feb 2021
- Due
- 31 Mar 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Mesoblast intends to meet with the FDA during Q1 2021 through a well-established process to have further discussions on the potential for accelerated approval of remestemcel-L”
What we found
Evidence strength A What the grades mean
The company did not confirm meeting with the FDA regarding remestemcel-L accelerated approval within Q1 2021; later filings indicate ongoing discussions but do not confirm the specific Q1 meeting occurred.
-
A Mesoblast Ltd. 6-K filed 2021-04-01
“Mesoblast expects to meet with the United States Food and Drug Administration (FDA) under a well-established regulatory process to discuss the fastest pathway to licensure of remestemcel-L” ✓ confirmed on the page
-
A Mesoblast Ltd. 20-F filed 2021-08-31
“requested meetings with FDA are delayed by a minimum of 3 months while the public health crisis is in effect” ✓ confirmed on the page
Market reaction: the shares moved -0.3% against the S&P 500 over the three sessions around the disclosure (31 Mar 2021 to 6 Apr 2021). What this measures
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 other
- Indicative materiality
- Medium rules
- Action
- Meet
- Deliverable
- FDA meeting regarding remestemcel-L
- Where
- United States
- Language
- Aspirational (“aims”, “intends”)
- In the company’s control
- Medium
- 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: disagreesClaude (Anthropic) re-read the evidence blind and read it as “Late”.
- 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-2021-MESO-022753 · Corrections policy