Submit pre-Investigational New Drug meeting package to the FDA
Deadline not yet reached (65 days left)
- Announced
- 5 Aug 2026
- Due
- 31 Dec 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“anticipated submission of its pre-Investigational New Drug (IND) meeting package to the U.S. Food and Drug Administration by year-end.”
What we found
The deadline has not passed yet, so there is nothing to check. We look for evidence starting 30 days after 31 Dec 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
- Submit
- Deliverable
- pre-IND meeting package
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- Depends on
- Regulatory
Tell me what happens
This deadline has not been settled yet. We check 30 days after it passes. Get an email when we record the outcome.
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- OutcomeNot yet assessed. Nothing is judged before the deadline.
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Report an error in this entry Reference: KI-C-2026-ADMA-003445 · Corrections policy