Novan Announces Receipt of Written Minutes from Type C Meeting with FDA Regarding Development of SB206
Novan, Inc. (NOVN)
Last novan, inc. earnings: 11/12 04:23 pm
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Source: GlobeNewswire
Enrollment of first patient targeted for September 2020Top line results expected late in the second quarter of 2021 based on anticipated timeline MORRISVILLE, N.C., April 30, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq:NOVN) today announced that the Company has received meeting minutes from the April 1, 2020 Type C meeting with the U.S. Food and Drug Administration (“FDA”) regarding SB206 for the treatment of molluscum contagiosum (“molluscum”). Based on guidance the Company received during the meeting and subsequently contained within the meeting minutes, Novan is preparing to conduct one additional pivotal trial (“B-SIMPLE4”), which, if successful, could be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application (“NDA”). In addition, the FDA provided guidance with regard to the study design for B-SIMPLE4 and expectations for a future NDA submission, which has been incorporated in the B-SIMPLE4 preliminary trial design cha
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