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I think the real tragedy is that Imclone's apparent mismanagement of the application process has caused a substantial delay in patients getting the drug. Colorectal cancer kills about 57,000 Americans per year, and the last I heard, there were 10,000 pts. on the waiting list for Erbitux. Erbitux would probably help a fraction of them. It's not a miracle drug, but it appears to be an incremental improvement over existing drugs, which is generally the best you get w/ a new cancer med. At any rate, the delay in getting Erbitux to market is probably costing thousands of lives.

Imclone's defenders say that the FDA's guidance re the application was confusing and changed with time. I wonder if the FDA couldn't have just gone ahead and given the drug conditional approval and required Phase IV (post-approval) studies to address their concerns.

The FDA has been unusually difficult to deal with lately, which is the principal reason Biotech stocks are in the pits. Nearly every "large molecule" drug application in the past year has resulted in the FDA asking for more data, which generally results in about a year's delay, and occasionally, new trials. The FDA has been without a director throughout President Bush's tenure, and everyone there is afraid of making mistakes. Loath as I am to criticize this President, I wish he'd at least make a nomination, because things are badly bogged down at the FDA, and they need someone to get them moving. I've become so impatient that I'd be pleased for just about anyone to get the job, as long as Teddy Kennedy doesn't like him.

If you want to talk about colon cancer and FDA scandals, do some research on Cell Pathways (in Horsham PA) and their drug "Aptosyn".

People are dying daily that could be saved by their cheap, safe, effective drug -- a metabolite of a drug that's been on the market for decades -- but, too many Big Pharma bucks would be lost if it was approved.

I'll give you one tidbit: at the FDA ODAC hearing for Celebrex (for FAP label), they had a witness testify about the investigational drug she was given, and how it miraculously saved her life. After she presented her story, the drug was approved.

The ODAC committee was not told, however, that the drug she was talking about was not Celebrex. And she was not told that the ODAC committee was not meeting to discuss the drug she had taken.

What drug had she taken?

Aptosyn.

The word "scandal" doesn't do justice to the sh*t that goes on in that world.