Submit IDE for Ovaprene
Delivered after 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
- 31 Dec 2021
- Delivered
- January 2022
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Ovaprene IDE submission planned for 2H2021”
What we found
Evidence strength A What the grades mean
Filings state the Ovaprene IDE review process was initiated with the FDA in January 2022, after the 2H2021 deadline.
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A Dare Bioscience, Inc. 10-K filed 2022-03-31
“Our IDE submission was subsequently converted to an IDE pre-submission so that the FDA could engage in a collaborative discussion with us” ✓ confirmed on the page
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A Dare Bioscience, Inc. 10-Q filed 2022-05-12
“In January 2022, we initiated an Investigational Device Exemption, or IDE, review process with the FDA for a multi-center, non-comparative, pivotal Phase 3 clinical study of the safety and efficacy of Ovaprene” ✓ 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 filing
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- Ovaprene IDE submission
- 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, 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-DARE-023888 · Corrections policy