Word: fda
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Dates: during 2000-2009
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...only stockholder of the biotech firm who is coming under suspicion for possible insider trading. Documents obtained by TIME show dumping of ImClone stocks by its executives that dwarfed Stewart's $228,000 sale. And their trading preceded Stewart's by weeks, starting just after Food and Drug Administration (FDA) officials met privately with an ImClone vice president last Dec. 4 and informally signaled there could be licensing problems for the company's cancer drug Erbitux. The FDA formally turned down a review of the drug on Dec. 28, a day after Stewart traded her shares...
...spokesman for Landes said he notified his broker a month before the Dec. 4 FDA meeting that he planned to sell. But investigators question why he waited until Dec. 6 to execute the trade. Martell did not return calls for comment...
Landes, the ImClone official with veto power over internal stock trading, has become a central focus of investigators, sources tell TIME. On the night of Dec. 26, he spent 17 minutes on the phone with CEO Sam Waksal, records show. Waksal had just learned that the FDA would announce its negative decision on Erbitux in two days. Later that night Waksal drafted a note, marked "Urgent--Immediate Attention Required," to his Merrill Lynch broker, Peter Bacanovic, sources say. Stopped from trading by the firm's blackout, Waksal gave instructions to transfer $4.9 million in stock to the account...
Phone records are also helping investigators pin down just how Stewart may have been tipped off to FDA plans before selling her shares Dec. 27. Sources say her assistant has signed an affidavit revealing that Bacanovic, who was also Stewart's broker, called Stewart's office between 10 a.m. and 11 a.m. on Dec. 27, shortly after Aliza's shares were dumped, and left a message that "ImClone is going to start trading downward." Stewart called Bacanovic's office at 1:30 p.m. Her stock was sold 10 minutes later, sources say. Stewart has denied that she engaged...
...necessarily. An advisory panel to the Food and Drug Administration (FDA) last week reviewed new safety data on saline implants, which were approved by the FDA only two years ago. (Silicone-gel implants were never formally approved and are now available only in medical studies.) The review is timely. More than 200,000 women went under the knife last year to acquire bigger breasts. That's five times the number a decade ago. And 80,000 had implants after mastectomies. What could be worrisome about a sac of salt water? Plenty, according to the FDA hearings: more than...