Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: jayhawk969 who wrote (5760)	2/27/2002 9:38:56 AM
From: Ian@SI	Respond to of 52153

My 2¢ worth. 1. New FDA commissioner helped trigger a rotation back into the sector. 2. For the last few years, money has rotated from sector to sector. It's quite possible that Biotech is being viewed as an attractive sector after the brutal selloff for no fundamental reason... Ian ++++++++ More IMCL stuff: Editorial in today's WSJ ++++++++++ The Real ImClone Scandal The headlines about troubled ImClone have been all about its stock price and whether management sold stock based on insider information. But the real news took place yesterday, when the Food and Drug Administration finally met with ImClone to discuss the approval of its promising cancer drug Erbitux. For whatever the financial shenanigans of ImClone executives, the scandal here is delayed access to what just about everyone but the FDA agrees could be a life-saving medicine. As Dr. Robert Mayer of the Dana-Farber Cancer Institute in Boston recently told the Associated Press, "The bottom line is that the drug works in some people . . . . Many of us have been very enthusiastic." Instead of fuming at ImClone execs Sam and Harlan Waksal, angry shareholders might better aim their anger at the FDA. Erbitux is one of a promising new class of cancer drugs that disrupt the biochemical signals that make tumors grow. Their action is far more specific than chemotherapy drugs, which poison the whole body, and they're the only real hope right now for patients for whom chemo alone doesn't work. ImClone hired the world-renowned Dr. Leonard Saltz of Memorial Sloan-Kettering Cancer Center to test Erbitux in combination with a chemo agent called irinotecan. It thought the 22.5% response rate in the preliminary study was promising enough to justify asking the FDA for "fast-track" review. More than 1,000 patients have participated in different Erbitux trials around the world, and the only side effect of the drug appears to be acne in some patients. European approval is expected next year. But on December 28 the FDA declined even to review ImClone's application, leading to allegations ImClone executives had misled investors about the status of the drug. Well, we've had a good look at the leaked letter detailing the FDA's reasons for rejecting ImClone's study, and we'd say it says more damning things about the agency than it does about ImClone. To be sure, it goes into detail about patient data it wishes ImClone had provided. But the bottom line is a demand for additional studies "directly comparing the efficacy of single agent Cetuximab [Erbitux] to the combination of Cetuximab plus irinotecan." In other words, although the FDA granted fast-track review of Erbitux last year, it apparently never had any intention of approving the drug based on the kind of study it knew ImClone was doing. Moreover, the FDA now wants critically ill patients to endure a study to test Erbitux alone, even though ImClone has good reasons to believe the drug is about twice as effective when used in combination with a traditional chemotherapy agent. Isn't there some famous medical oath about doing no harm? Sometimes the FDA doesn't seem to care that the drugs it reviews are for sick people, not rats. Sure, the best data would come from studies involving thousands of subjects, tested over many years with placebos, the new drug and other available therapies. But it's hardly ethical to deny human study volunteers the best chance for survival based on available information. Nor is it ethical to withhold promising drugs from the broader public while the numbers are verified to the highest degree. Fred Santino of Massachusetts, whose wife died of colorectal cancer last May while unsuccessfully seeking treatment with Erbitux, sums up patient frustration with FDA foot-dragging: "It's a shame it's not out there . . . . Cancer is bad enough without all of this other stuff going on." That "other stuff" seems to include the Waksals' dating habits (Martha Stewart and daughter) and their irritating fondness for the high life. But entrepreneurs are rarely pillars of the establishment; that's why they take risks. The reason for ImClone's stock collapse wasn't anything the Waksals did in any event. The cause was the leak of the FDA's foot-dragging on Erbitux. Not that the stock doesn't still have some backers, notably investor Carl Icahn, who just got permission to buy up to 40% of ImClone. The solution isn't to punish ImClone but for the FDA to disclose more about its drug reviews, as guidance to both investors and patients. People shouldn't have to wait for leaked letters to understand what the bureaucracy is up to, and getting it on record could prevent nasty surprises in the future. This is a job for the next FDA commissioner, if Senate liberals would ever let the White House nominate someone who understands that the problem isn't stock speculation but helping the desperately ill.

To: jayhawk969 who wrote (5760)	2/27/2002 9:39:38 AM
From: Biomaven	Read Replies (1) \| Respond to of 52153

J.D.: How do we get the inside information on yesterdays trigger? We can't - nobody who knows is going to be talking. But note that the market is basically chaotic, and sometimes a small trigger can have a big impact. There are big computer-driven trading programs that can serve as force multipliers - if they see movement in one stock they buy or sell other stocks that are related to the first stock. And of course the T/A crew have some impact on the market as well, again generally serving to magnify and prolong trends. Peter