Daré Bio up 8% premarket on FDA status for DARE-BV1

Thinly traded nano cap Daré Bioscience (NASDAQ:DARE) is up 8% premarket on light volume in reaction to the FDA’s granting of Qualified Infectious Disease Product (QIDP) status for candidate DARE-BV1, a novel thermosetting hydrogel containing clindamycin phosphate 2%, for the potential treatment of women with bacterial vaginosis.

QIDP status provides for for more frequent interaction with the FDA review team, a rolling review of the marketing application, a shortened review clock and a five-year period of market exclusivity for the indication, if approved.

A 250-subject Phase 3 should launch next quarter which, if successful, should be sufficient to support a U.S. marketing application.

https://seekingalpha.com/news/3490628-dare-bio-8-percent-premarket-qidp-tag-dare-bv1