Zalicus Inc (ZLCS)

[BioSpecialist]

Approval is coming soon !!!

"On March 23, 2009, Neuromed announced that Exalgo met the primary endpoint in a pivotal phase III clinical trial. On May 22, 2009, Neuromed submitted a response to an Approvable Letter to the U.S. Food and Drug Administration seeking approval for Exalgo for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. On June 12, 2009, the FDA informed Neuromed that the Exalgo submission would be classified as a Complete, Class 2 Response with a corresponding PDUFA date of November 22, 2009."