Health Canada Grants Apricus Biosciences (APRI) Pre-NDS Meeting for MycoVa(TM) for the Treatment of Onychomycosis
5/11/2012 9:30:55 AM
SAN DIEGO, May 11, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that Health Canada has granted the Company's request for a Pre-New Drug Submission ("Pre-NDS") meeting to obtain regulatory guidance from the agency for MycoVa™, the Company's topical treatment for onychomycosis, or nail fungus. The meeting is scheduled to take place July 18, 2012. Apricus Bio expects to obtain feedback from Health Canada regarding the suitability of its Phase 3 development program to support a New Drug Submission ("NDS") in Canada. In addition, the Company is seeking guidance from the US Food and Drug Administration and will be filing for guidance from the European Health Agency.