Other cases - FDA cancellationssee below - hopefully this happens to ISA. Either way, Lux or ISA should be clarifying or "offering" an opinion of what is going on. We all know the FDA has considerable data from the clinical trials.
ISA's future hangs in the balance.
What worries me is Foster's comments, "
"The review process in Europe is also underway and expected to be completed by the end of February 2011," stated Dr. Robert Foster, President and CEO of Isotechnika Pharma.
Why is he deflecting to Europe now? He could have used this sentence to elaborate on what is going on?
Wyeth (NYSE: WYE) announced today it was notified by the U.S. Food and Drug Administration (FDA) of the Agency's decision to cancel its September 7, 2006 Psychopharmacologic Drugs Advisory Committee meeting. The meeting was originally scheduled to provide a forum for FDA advisors to discuss and review data included in Wyeth's New Drug Application (NDA) for desvenlafaxine succinate extended release for the treatment of major depressive disorder. After further review of the data, the FDA decided it was no longer necessary to hold the advisory committee meeting before issuing its action letter, which is expected in October 2006.
Wyeth is encouraged by this development and believes that its comprehensive clinical trials program for desvenlafaxine succinate supports the product's approval. The Company submitted its NDA to the FDA for desvenlafaxine succinate, a dual serotonin-norepinephrine reuptake inhibitor, in December 2005.
Facts About Depression
Depression is the most common serious mental disorder worldwide.
-- Depression affects approximately 121 million people worldwide and is the fourth leading cause of disability and premature death.
-- The World Health Organization projects that by the year 2020, depressive disorders will become the second-leading cause of disability worldwide.
-- Depression is one of the most prevalent
mental health conditions in the United States, affecting approximately 14.8 million American adults each year.
-- Women suffer from
depression twice as often as men.
More treatment options are needed.
-- Researchers estimate that approximately 50 to 60 percent of patients suffering from depression respond to antidepressant therapy, leaving a large percentage of patients with unresolved depression.
-- Patients who experience one episode of depression have a 50 to 60 percent chance that it will recur.
Wyeth Is Committed to Neuroscience Research and Development As a leader in neuroscience, Wyeth's discovery and development of desvenlafaxine succinate demonstrates its commitment to developing pharmaceutical products to help address the unmet needs of patients living with mental illness. In addition to the investigational compound desvenlafaxine succinate for major depressive disorder, the Company also has active research programs in other mental health areas, including
bipolar disorder,
schizophrenia, and
Alzheimer's disease.