Novan Completes End-of-Phase 2 Meeting and Provides Additional Business Updates
MORRISVILLE, N.C., March 11, 2019 (GLOBE NEWSWIRE) — Novan, Inc. (“the Company” or “Novan”) (Nasdaq:NOVN) today announced a number of recent business advancements.
Novan concluded an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding SB206 for the treatment of molluscum. The Company has also received the written minutes from that meeting. Based on guidance from both the meeting and minutes received, the Company believes that pivotal Phase 3 clinical trials for molluscum are positioned to be initiated in the second quarter of 2019, subject to securing additional financing or partnering. Novan has engaged a contract research organization (CRO) for the execution of the pivotal trials and, if the trial is initiated on this timetable, top-line results would be expected in late 2019 or during the first quarter of 2020.