According to the complaint filed on October 30, 2009, Avanir is focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of chronic' diseases. Its lead product candidate, Zenvia, is being developed for the treatment of pseudobulpar affect ("PBA"), a neurological disease that causes sudden and unpredictable episodes of crying, laughing, or other emotional displays.
On October 31, 2006, Avanir disclosed that the FDA had issued an "Approvable Letter" indicating that Avanir's New Drug Application ("NDA") for Zenvia was approvable, subject to Avanir satisfying the FDA's concerns about the safety and efficacy of Avanir. This Approvable Letter, which Avanir's then CEO called a "negative surprise", was a far cry from the statements Defendants made during the relevant time period, in which all Defendants all but guaranteed that the FDA would approve the FDA for Zenvia. Not surprisingly, when the truth was revealed, the price of Anavir’s shares collapsed to as low as $3.98 per share, down 54% from the previous day closing of $7.40 per share.
On March 29, 2010, the Court dismissed the case without prejudice for want of prosecution.