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Strategies & Market Trends : Zeev's Turnips - No Politics -- Ignore unavailable to you. Want to Upgrade?

To: Paul A who wrote (33946)	2/27/2002 8:17:10 AM
From: Zeev Hed	Read Replies (2) \| Respond to of 99280

I did not, I took two profitable trades yesterday and stepped aside. I am not chasing it either. Zeev

To: Paul A who wrote (33946)	2/27/2002 8:28:05 PM
From: LTK007	Respond to of 99280

press release obviously scared the shorts to run to cover.But whether it is to be actually good news remains a major question <<Wednesday February 27, 5:54 pm Eastern Time ImClone Soars on Positive FDA News, but Drug Approval Remains Far From Certain By THERESA AGOVINO AP Business Writer NEW YORK (AP) -- Shares of ImClone Systems Inc. surged Wednesday after the company said the Food and Drug Administration may allow it to use data from a European trial to support efforts to gain approval of its star drug. But the future of Erbitux, a highly touted cancer treatment, remains far from certain. ImClone shares catapulted 32 percent, or $5.01 a share, to $20.53 after the company said the FDA told it Tuesday that it would consider accepting Erbitux data from an ongoing trial by Germany's Merck KGaA, which owns the drug's European rights. In December, the FDA rejected ImClone's application to review Erbitux as a treatment for colorectal cancer, saying it lacked important data. Some feared the FDA would require ImClone to conduct new trials, which would likely have postponed the drug's approval until 2005. If the company were allowed to combine the Merck data with revised information its own studies, the drug could be approved as early next year. People with knowledge of the meeting said the FDA seemed very receptive and eager to help ImClone through the process. The FDA doesn't comment on meetings. ``I think this is a positive because it omits the worst-case scenario of having to do new trials,'' said Jason Kantor, an analyst at J.P. Morgan. ``But it certainly isn't a closed deal. There are still obstacles.'' ImClone didn't return calls for comment. But in a statement, chief executive Sam Waksal said, ``We view the meeting with the FDA as very productive. The meeting provides us with direction on an approach and a process for resubmitting the Erbitux BLA (filing), which is expected to include both U.S. and European clinical trial data.'' The specifics of what the FDA would require in a resubmitted Erbitux application remain unclear. The Merck trial is expected to be done by year's end. Analysts agree Merck's trial design is much better than ImClone's study because it follows patients receiving Erbitux alone as well as patients getting the drug plus chemotherapy. ImClone's study only followed patients on a combination therapy -- so the FDA said it couldn't determine whether Erbitux was responsible for shrinking patients' tumors. Still, no one knows if Merck's data will show the same results as ImClone's study, which said Erbitux shrank tumors in 22.5 percent of the 120 patients. Nonetheless, analysts said the FDA's decision makes it less likely that Bristol-Myers Squibb Co. [NYSE:BMY - news] will walk from it partnership with ImClone as it had previously threatened. In September, Bristol-Myers agreed to pay $2 billion for a 19.9 percent stake in ImClone and 40 percent of Erbitux's profits. It has already paid the biotech company $1.2 billion but has written off $735 million of its investment since ImClone stock plummeted after the FDA rejections. Even with Wednesday's jump, the stock is still down 72 percent form the high it reached in early December. The FDA rejection touched off a cascade of shareholder lawsuits alleging ImClone mislead investors, three federal investigations into those allegations and a public feud with Bristol-Myers. Bristol-Myers sought to restructure its deal with ImClone. It wanted to temporarily remove the biotech company's top management, eliminate $800 million in future payments, and get a bigger share of Erbitux profits. ImClone refused. In a statement, Bristol-Myers said the FDA meeting, which it attended, ``provided clarity'' but said it was still reviewing its relationship with the biotech firm. Bristol-Myers still has serious misgivings about ImClone's ability to push Erbitux through the regulatory process given its botched first attempt, people closer to the situation said. Others worry that Waksal and his brother Harlan, ImClone's chief operating officer, will be too distracted defending the firm against shareholder lawsuits and federal probes to concentrate on Erbitux. Gruntal & Co. analyst Cory Kasimov believes the brothers will work tirelessly on the approval to prove they can run the company and dispel charges made by shareholders. ``They (the Waksals) may have taken a a few short cuts the first time. But they learned lessons the hard way and I think they will work hard to avoid more mistakes,'' he said. Email this story - Most-emailed articles - Most-viewed articles