NexMed management has been advised that Health Canada is continuing to review its response for acceptance, and the company expects to hear from the agency within the next 30 days.
An acceptance of the response by Health Canada is expected to trigger a new, 150-day review cycle by the NDS reviewers for a final approval or rejection of the marketing application.
Earlier, on April 23, 2010, NexMed had received delivery confirmation of its response to the CMC (Chemistry, Manufacturing and Controls) concerns previously raised by Health Canada related to its Vitaros, which was filed in February 2008, which has provided Health Canada with a 45-day screening for acceptance process of the Response by their Regulatory Project Management group, or until approximately June 4, 2010.