>> The complaint alleges that the defendants made false and misleading statements regarding the progress of the Company's Biologics License Application ("BLA") for Provenge. According to the complaint, the FDA conducted a pre-approval Chemistry, Manufacturing and Controls (CMC) inspection of Dendreon's Hanover, New Jersey manufacturing facility in mid- February 2007 and issued to Dendreon what is known as an FDA Form 483, Inspectional Observations Report, which cited various violations of FDA regulations at the Dendreon facility. Pursuant to FDA regulations, the complaint alleges, the issuance of a Form 483 made it highly likely that FDA approval would be delayed substantially past May 15, 2007, the anticipated FDA review date.
According to the complaint, the defendants repeatedly failed to disclose this information to investors and made false and misleading statements, thereby artificially inflating Dendreon's stock price. The complaint further alleges that certain officers and directors traded on this information without disclosing it to the investing public. The complaint alleges that the Company only began disclosing this information as part of its May 9, 2007 announcement that the FDA had issued a Complete Response letter denying approval for Provenge, which letter cited the same CMC issues allegedly known to the defendants in February. As a result of this disclosure, Dendreon stock lost nearly 70% of its market value, causing significant losses to investors. <<
Dr. Gold and perhaps others could end up paying a huge fine, wearing an orange jumpsuit, or both.
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