COMPLAINT FOR VIOLATIONS OF FEDERAL SECURITIESLAWS
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12345678910111213141516171819202122232425262728risks associated with the drug. As a result of Vivus’s false statements, the Company’s stock traded at artificially inflated prices during the Class Period, reaching a high of $13.68 per shareon May 18, 2010.4.
On July 15, 2010, the Endocrinologic and Metabolic Drugs Advisory Committeeof the FDA (the “FDA Panel”) composed of independent medical experts whoserecommendations carry great weight within the FDA approval process, voted 10 to 6 against theapproval of Qnexa based upon an “overall risk-benefit assessment” for use in obese individualsand certain overweight patients with other health problems such as diabetes or high bloodpressure.
Even some of the panel members who voted “yes” noted that it was “a very fine linebetween a yes and a no vote,” and that they could have voted no.5.
The FDA Panel members who voted “no” cited “serious” and “life-threatening”side effects in Qnexa’s trial data, including birth defects, depression, anxiety, sleep disorders,cognitive disorders, metabolic acidosis (too much acid in the body fluids), and an unknownimpact on the heart as reasons they could not recommend the drug’s approval.6.
The FDA Panel refused to recommend Qnexa as a chronic or “lifetime” drugtherapy because the limited data made it “difficult if not impossible” to weigh the long-termsafety of the drug. Only 56 weeks of safety data were provided from the clinical studies eventhough, if approved, the expected time frame for Qnexa use would be much longer since obesityis a “chronic disease requiring chronic treatment.” According to Dr. Lamont G. Weide, a votingpanel member and endocrinologist at the University of Missouri, Kansas City, “[t]he realquestion is when we look at this drug is how safe it is and for how long because this is likely alifetime therapy.” Dr. Weide also specifically stated, “I feel uncomfortable with a year’s worth
The sixteen voting FDA Panel members included: Dr. Thomas P. Bersot, Dr. David M.Capuzzi, Dr. Allison B. Goldfine, Dr. Abraham Thomas, Dr. Lamont G. Weide, Dr. Elaine H.Morrato, Dr. Sanjay Kaul, Dr. Kenneth D. Burman, Dr. Susan R. Heckbert, Dr. Katherine M.Flegal, Dr. Jessica W. Henderson, Dr. Janet D. Cragan, Ms. Melanie Coffin, Dr. Ed J. Hendricks,Dr. Michael A. Proschan, and Dr. Michael A. Rogawski.