I saw this article dated December 13th. This company is acting like approval is all but imminent but the price sure is not reflecting that.
Alexa prepares for pharmaceutical sales of ADASUVE after committee recommendation from FDA
Dec 13, 2011 02:21 PM
Alexa Pharmaceuticals Incorporated has announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the Food and Drug Administration (FDA) has given the preliminary go-ahead for the pharmaceutical sales of ADASUVE for the treatment of agitation in psychiatric patients.
The move is a major step in the advancement of the breakthrough drug, which is a single dose treatment for patients with schizophrenia or biopolar mania, often called manic depression.
Thomas B. King, Alexa Pharmaceutical's president and chief executive officer, said the company has set a target date of February 4 to get the treatment on the U.S. market.
"We appreciate the Advisory Committee's recognition of agitation as a serious and underappreciated symptom of schizophrenia and bipolar disorder," King added. "If approved, we believe ADASUVE represents a valuable treatment option for patients and physicians alike. We look forward to continuing to work toward our goal of bringing ADASUVE to market in 2012."
ADUSUVE is also currently under review for the potential pharmaceutical sales on the European market.
According to the National Institute of Mental Health, approximately 1 percent of Americans suffer from schizophrenia.
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