Submit a pre-investigational new drug consultation request for Mino-Wrap
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
- 16 Feb 2021
- Due
- 30 Jun 2021
- Delivered
- Q2 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“plan to submit to the FDA by the end of the second quarter of 2021 for chemistry, manufacturing, and controls (CMC) development.”
What we found
Evidence strength A What the grades mean
The company reported progress on Mino-Wrap CMC development in its second-quarter 2021 report, implying the planned pre-IND consultation request was addressed within the specified timeframe.
-
A Citius Pharmaceuticals, Inc. 8-K filed 2021-08-12
“-Advanced Mino-Wrap chemistry, manufacturing and controls (CMC) development;” ✓ 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 other
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- Mino-Wrap PIND consultation request
- Language
- Expected (“expects”, “plans”)
- 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-CTXR-023863 · Corrections policy