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

To: Vector1 who wrote (4224)	3/3/1998 12:03:00 PM
From: Biomaven	Read Replies (1) \| Respond to of 9719

V1: Buried near the bottom of their 10K: Breast thermographic devices (such as the BreastAlert device) intended to be used by physicians as an adjunct to other established clinical detection methods for breast disease are currently classified as Class I devices. On January 17,1984, FDA granted 510(k) Market Rights to the then owner of the technology underlying the BreastAlert device. The BreastAlert device may be marketed by the owner of the 510(k) Market Rights without further FDA authorization when used adjunctively by the physician. Scantek assigned the 510(k) Market Rights for the BreastAlert device to the Company in October 1995. Prior thermographic devices which, unlike the BreastAlert device, involved imaging rather than measurement of temperature differences, did not perform as intended. In 1983, the Office of Health Technology Assessment ("OHTA") of the Department of Health and Human Services issued a report stating that thermography needed further development and should not be used alone for diagnostic screening for breast cancer. In 1984, the Health Care Financing Administration ("HCFA") withdrew coverage for thermography under Medicare as a diagnostic screening method for breast disease. In 1991, based upon reports which addressed the use of thermography in neurological and musculoskeletal conditions, the American Medical Association ("AMA") passed a resolution stating that thermography had not been proven to have value as a medical diagnostic test. In 1992, HCFA withdrew Medicare reimbursement for all other uses of thermography. In 1993, the AMA adopted a resolution stating that the use of thermography for diagnostic purposes could not be recommended at that time. Based upon the reservations about the use of thermography for diagnostic purposes expressed by OHTA, HCFA and AMA, there is a risk that FDA could reevaluate the bases upon which it granted the Company's 510(k) Market Rights in 1984 and classified devices such as the BreastAlert device as Class I devices in 1988. If FDA were to reevaluate these decisions and conclude that additional data were necessary to support authorization to market the BreastAlert device, it could rescind previous 510(k) Market Rights for breast thermographic devices and/or reclassify these devices from Class I medical devices to Class III medical devices (which would effectively vitiate the Company's 510(k) Market Rights and require filing of a PMA. In either event, the Company would be required to cease marketing the BreastAlert device until it filed a PMA with FDA and received a new approval to market the BreastAlert device.

To: Vector1 who wrote (4224)	3/3/1998 7:08:00 PM
From: Cytokine1	Read Replies (2) \| Respond to of 9719

VD's MODEL PORTFOLIO 3/3/98 Change $3920 UP 1.69% Started 4/9/97, $100K . INDEX ^IXB UP 1.31% VD Inc: From Transgenic Goats to Radioactive Antibodies # CURRENT DAILY CURRENT COST TOTAL %GAIN/ % OF SYMBOL SHRS PRICE CHANGE %CHG VALUE SHR COST LOSS TOTAL ======= ======= ======= ======= ======= ======= ======= ======= ======= ======= CLTR 1000 23.75 -0.63 -2.56% 23750 10.88 10875 118.4% 10.1% INCY 580 45.75 0.50 1.10% 26535 24.28 14080 88.5% 11.3% GZTC 2770 13.38 0.63 4.90% 37049 7.74 21432 72.9% 15.7% GENZ 530 31.47 1.72 5.78% 16678 23.50 12455 33.9% 7.1% BGEN 400 46.63 2.75 6.27% 18650 35.88 14350 30.0% 7.9% LGND 2800 15.31 0.31 2.08% 42875 12.43 34810 23.2% 18.2% MOGN 3000 5.13 -0.06 -1.20% 15375 5.125 15375 0.0% 6.5% AVIR 500 24.50 -0.38 -1.51% 12250 25.00 12500 -2.0% 5.2% FUSE 400 11.06 -0.56 -4.84% 4425 14.19 5675 -22.0% 1.9% GLFD 500 21.38 -0.69 -3.12% 10688 28.25 14125 -24.3% 4.5% ABSC 400 10.44 -0.44 -4.02% 4175 14.94 5975 -30.1% 1.8% GENZL 2015 7.69 0.44 6.03% 15490 10.36 20880 -25.8% 6.6% REGN 1000 7.63 -0.13 -1.61% 7625 12.00 12000 -36.5% 3.2% SUBTOT ______ ______ ______ ______ 235565 194532 21.1% 100.0% CASH ______ ______ ______ ______ 0 MARGIN MTCE. EQUITY 49.8% MIN 30% (118200) BUYING POWER $ ______ 0 NAV = ______ ______ ______ ______ 117365 100000 17.4% ^IXB INDEX 317.01 4.10 1.31% 302.42 4.8%