Dare Bioscience Investor Presentation Deck
OvapreneⓇ - Collaborative Research Agreement with NIH¹
July 2021 - Daré announced that funding and
clinical operations support for the Phase 3
will be provided by the National Institutes of
Health's Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD) Under the CRADA
NIH
Cooperative Research and
Development Agreement
(CRADA) for the Pivotal
Phase 3 Study
●
The pivotal Phase 3 study will be supported by the NICHD's
Contraceptive Development Program which oversees the Contraceptive
Clinical Trial Network (CCTN) established in 1996 to conduct studies of
investigational contraceptives. The Phase 3 study will be conducted
within the CCTN with the NICHD contractor Health Decisions Inc.
Daré will be responsible for providing clinical supplies of Ovaprene® and
coordinating interactions with and preparing and submitting supportive
regulatory documentation to the FDA.
Under the CRADA, Daré also agreed to contribute $5.5 million toward
the total estimated cost to conduct the pivotal Phase 3 study, payable in
four payments. Three payments totaling $5 million have been made.
"This collaboration between Daré and NICHD marks an important milestone in Women's Healthcare Innovation. Women are at the center of
everything we do and we are so pleased to continue to partner with Daré in support of our mission We're For Her to provide women with education
and access to contraceptive options," said John Berrios, Bayer's Head of Women's Healthcare.
1. https://ir.darebioscience.com/news-releases/news-release-details/dare-announces-collaborative-research-agreement-crada-pivotal
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