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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Cytokine1 who wrote (7894)	4/24/2000 12:06:00 AM
From: Vector1	Read Replies (1) \| Respond to of 9719

The FDA is up to no good again and we could see some severe volatility in CELG. Has the FDA heard of the First Amendment. The evidence of Thalidomide's effectiveness in Multiple Myeloma is nothing short of compelling. We are talking about deadly diseases. No one is pushing the drug to pregnant woman. I thought the Bloomberg article is well balanced Celgene Promoted Thalidomide Drug for Unapproved Uses, FDA Says By Brian Reid Washington, April 21 (Bloomberg) -- Celgene Corp. promoted unapproved uses of its thalidomide drug to doctors, the U.S. Food and Drug Administration said in a warning letter. Thalidomide, which is sold by Celgene as Thalomid, was linked to severe birth defects in the 1950s and 1960s. The drug was first approved by the FDA in 1998 for a rare complication of leprosy. Use of the drug is severely restricted and close monitoring of patients is required. The FDA said the threat of birth defects arising from improper administration of the drug to pregnant women requires extra vigilance. ``Perhaps more than any other available drug, the need to provide and distribute thalidomide responsibly is essential to public health,' the agency said in the warning letter, which was faxed to the company today. The company's offices were closed and phone calls seeking comment were not returned. The FDA said that in several cases, Celgene sales representatives asked doctors to consider using the drug to treat cancer. Though studies of the drug, including one published last November in the New England Journal of Medicine, have shown the drug appeared effective in treating a deadly form of blood cancer called multiple myeloma, the agency hasn't approved that use of the drug. Doctors may decide to use the drug to treat the cancer but sales representatives are not allowed to promote that use. Celgene marketing has drawn FDA criticism before: The FDA raised concerns that the company was illegally promoting the drug in late 1998 and said that it considered the recent problems to be evidence of ``a continuing pattern and practice of violative behavior.' The agency asked the company to stop all improper promotion of the drug and forward a copy of the warning letter to all sales representatives. The agency also asked the company to develop a plan to avoid similar violations in the future. Off-label promotion has been important to the growth of Celgene's sales of Thalomid, analysts said. The company estimates that only about 1,000 people in the U.S. have the leprosy complication the drug is approved to treat, while about 40,000 patients have multiple myeloma. The FDA sends hundreds of warning letters to companies each year; only a small number result in significant agency action. Still, the letters can be the last notice before the FDA takes steps such as holding up shipments of a product or pursuing civil fines.

To: Cytokine1 who wrote (7894)	4/24/2000 7:45:00 PM
From: Cytokine1	Read Replies (1) \| Respond to of 9719

VD's MODEL PORTFOLIO 4/24/00 Change -$62981 DOWN -6.07% Started 4/9/97, $100K . INDEX ^IXB DOWN -4.59% YTD EQUITY CHANGE 44.9% # CURRENT DAILY CURRENT COST TOTAL %GAIN/ % OF SYMBOL SHRS PRICE CHANGE %CHG VALUE SHR COST LOSS TOTAL ======= ======= ======= ======= ======= ======= ======= ======= ======= ======= INCY 1000 73.25 -3.81 -4.95% 73250 34.26 34259 113.8% 7.5% BTRN 3000 6.69 -0.50 -6.96% 20063 2.25 6750 197.2% 2.1% NPSP 2000 9.50 -0.13 -1.30% 19000 5.50 11000 72.7% 2.0% CELG 5400 32.00 -4.00 -11.11% 172800 9.033 48780 254.2% 17.7% CGPI 2000 10.00 0.00 0.00% 20000 9.00 18000 11.1% 2.1% GZTC 1800 15.38 -2.00 -11.51% 27675 7.737 13927 98.7% 2.8% MOGN 2500 20.19 -1.94 -8.76% 50469 17.00 42500 18.8% 5.2% TRMS 2500 34.50 -2.75 -7.38% 86250 21.771 54427 58.5% 8.9% SEPR 2000 86.63 -2.63 -2.94% 173250 42.356 84713 104.5% 17.8% CLTR 5000 21.00 -1.25 -5.62% 105000 16.756 83778 25.3% 10.8% VRTX 1500 45.50 -1.31 -2.80% 68250 70.083 105125 -35.1% 7.0% PDLI 500 79.63 -4.44 -5.28% 39813 74.000 37000 7.6% 4.1% MLNM 1000 60.00 0.00 0.00% 60000 50.000 50000 20.0% 6.2% GLIA 3500 16.69 -1.38 -7.61% 58406 17.563 61469 -5.0% 6.0% STOCK ______ ______ ______ ______ 974225 651728 49.5% 100.0% SHORT SALE CREDIT ______ ______ 0 MARGIN MTCE. EQUITY 93.2% MIN 30% (65869) BUYING POWER $ ______ 842487 EQUITY (NAV) ______ ______ ______ 908356 100000 808.4% ^IXB INDEX 845.34 -40.66 -4.59% 302.42 179.5% NOTES: OPEN orders subject to available buying power--- Expenses for Fiscal yr ending 4/8/00 will be posted within two weeks? . . . 04/18/2000 0 MLNM split 2/1, 500 shrs credit 04/17/2000 0 CELG split 3/1, 3600 shrs credit