Submit a response to the FDA's Complete Response Letter for bitopertin
Deadline not yet reached (246 days left)
- Announced
- 26 Feb 2026
- Due
- 30 Jun 2027
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“expect to submit a response to the CRL and receive an FDA decision by mid-2027”
What we found
The deadline has not passed yet, so there is nothing to check. We look for evidence starting 30 days after 30 Jun 2027.
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
- CRL response submission
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- Medium
- 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-IRON-002230 · Corrections policy