Posted on 07/26/2002 6:32:48 PM PDT by white trash redneck
I am very pleased that you won that battle. There will be many more battles in the future. We need your cool headed wisdom and ability to write.
Adam Feuerstein, of TheStreet.Com, has been one of Imclone's harshest critics. He said in a column today, "By almost all accounts, Erbitux is a promising cancer drug, but for reasons still unexplained, ImClone executives blew it. Instead of nearing the FDA finish line, the company and its drug are just getting to the starting gate."
http://www.thestreet.com/tech/adamfeuerstein/10010676.html
What Sam Waksal is accused of is insider trading. It's alleged (and sadly, I'm inclined to believe) that he got an early heads-up from a Bristol Myers Squibb executive that Imclone was about to receive a Refusal to File (RTF) letter from the FDA for the Erbitux application. Dr. Pazdur has admitted that he inadvertently leaked word of the RTF letter to the BMS guy. I understand that Dr. Waksal allegedly sold shares of his own before the news was made public, and tipped offed others as well.
Erbitux is not dead. As Adam Feuerstein mentioned in today's article, Imclone is working with the FDA to re-apply for approval. The great significance of the RTF letter is that assuming that the drug is eventually approved (and most seem to expect is will be), Erbitux is expected to be at least a year late to market, and competing products may win approval first. "First to market" is a huge advantage in the drug business, as physicians are reluctant to switch to a new product if they already have experience with one with the same basic mechanism of action that they're comfortable with.
No one can be that naive.
There is so much corruption at the FDA that it boggles description. For anyone to say the above with a straight face is frightening.
The fact that even major pharmas have drugs rejected right and left on "technicalities" should by itself be all the evidence anyone needs to cut through your "logic".
But I'll wrap up by saying that I'd be interested to see if you extend your polyanna admiration of the ethics of that agency to the ATF, who has quite a track record of nailing "paperwork techicalities" too. I hope that you're at least consistent in your naivete.
Nice turn of phrase
It may be entitled......"EATING YOUR OWN CROW".... or ...."EATING YOUR OWN HUMBLE PIE"...or even "EATING IN THE BIG HOUSE"..
Me either
Where is that wascally Waksal?
The Feuerstein article I cited was not hot off the press, it was from back in February. Came across it while doing some fact-checking on Google for the bit I was writing. I misread "2/27/02" as "7/27/02".
By the way, Common Tator, while I respectfully disagree about the apparent merits of Erbitux, I surely appreciate your concern about medical scams. When I was a young enlisted kid in the Navy, I sold 60 days' accumulated leave to buy stock in what turned out to be a medical scam. That still hurts.
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.
You are absolutely right. No plea negotiations. Let everyone involved swing gently in the wind. We can expect further revelations and investigations into corporate malfeasence as this plays out. These "elitists" will turn on each other in an attempt to save their greedy selves. They must go down before individual investor confidence can be restored to the marketplace.
I think you meant to say "pen stripes", didn't you?
I can see it now.... A whole new line of Martha Stewert prison ware. BWAHAHAHAHA!
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