Jun 11 2010
NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, today provided an update on the status of its New Drug Submission ("NDS") with Health Canada for Vitaros®, the Company's topical treatment for erectile dysfunction.
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 will trigger a new, 150-day review cycle by the NDS reviewers for a final approval or rejection of the marketing application.
On April 23, 2010, NexMed reported that it had received delivery confirmation of its response to the CMC (Chemistry, Manufacturing and Controls) concerns previously raised by Health Canada (the "Response") related to its New Drug Submission for Vitaros, which was filed in February 2008. The delivery confirmation 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.
Management of NexMed also stated today that the Company is not currently selling shares of its common stock pursuant to the agreement with Brinson Patrick Securities Corporation. Further information concerning the agreement with Brinson is available pursuant to the Company's Form 10Q filed on May 13, 2010.
SOURCE NexMed, Inc.
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