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


To: Cytokine1 who wrote (5633)9/18/1998 12:53:00 AM
From: Vector1  Read Replies (2) | Respond to of 9719
 
Aviron says 1999 FluMist launch unlikely

By Ransdell Pierson

NEW YORK, Sept 17 (Reuters) - Aviron (Nasdaq:AVIR - news) said Thursday that due to continuing regulatory hurdles, there was only a ''low'' probability it would launch its experimental intranasal influenza vaccine, FluMist, by the 1999-2000 flu season.

''What is the probability? I would say low,'' Aviron Chief Financial Officer Fred Kurland told Reuters at the Carson Group biotech conference being held here.

The California biotech company submitted a Product License Application in July to the U.S. Food and Drug Administration (FDA) for a marketing approval of FluMist.

But Aviron disclosed on Aug. 31 the FDA had refused to accept the marketing application, noting the agency wanted more information on the drug's manufacturing process.

At the time, Aviron cautioned that the FDA might require another clinical trial to ensure that a new manufacturing process needed to make large commercial batches of FluMist would yield essentially the same vaccine as the one used in successful earlier clinical trials.

Kurland said Thursday that although the probability of a launch in time for the 1999-2000 flu season was low, the company still held out hope and planned to meet with FDA officials in coming months to better determine FDA requirements for accepting Aviron's FluMist marketing application.

Aviron previously said a new clinical trial would take at least six months to complete.

Although such a trial might delay the FluMist launch to the 2000-2001 flu season, Kurland said such a delay should give Aviron time to ramp up capacity to produce 20 million doses of the vaccine - four times the amount that would be available for a 1999-2000 launch.

He added the company was interested in staging a television, radio and newspaper direct-to-consumer advertising campaign in the summer preceding the FluMist launch.

''Probably the ideal time for the flu vaccine to be taken is September, when kids find themselves in closed classrooms starting to give each other the flu,'' Kurland said. ''So I would think August would be a good month'' to launch an eventual direct-to-con



To: Cytokine1 who wrote (5633)9/18/1998 9:30:00 PM
From: Cytokine1  Read Replies (1) | Respond to of 9719
 
VD's MODEL PORTFOLIO 9/18/98 Change $5044 UP 3.55%
Started 4/9/97, $100K . INDEX ^IXB UP 2.28%
YTD EQUITY CHANGE -34.4%

# CURRENT DAILY CURRENT COST TOTAL %GAIN/ % OF
SYMBOL SHRS PRICE CHANGE %CHG VALUE SHR COST LOSS TOTAL
======= ======= ======= ======= ======= ======= ======= ======= ======= =======
CLTR 1000 18.25 -1.00 -5.19% 18250 10.88 10875 67.8% 12.4%
SEPR 272 57.50 3.13 5.75% 15640 37.55 10214 53.1% 10.6%
GENZ 830 31.25 2.06 7.07% 25938 25.17 20893 24.1% 17.6%
AGPH 300 31.50 3.00 10.53% 9450 26.00 7800 21.2% 6.4%
MOGN 2000 6.25 0.56 9.89% 12500 7.00 14000 -10.7% 8.5%
DURA 200 15.63 1.81 13.12% 3125 24.63 4925 -36.5% 2.1%
INCY 1000 21.13 0.25 1.20% 21125 29.41 29409 -28.2% 14.4%
MLNM 300 14.31 0.06 0.44% 4294 18.63 5588 -23.2% 2.9%
GZTC 2000 4.88 0.25 5.41% 9750 7.737 15475 -37.0% 6.6%
ABSC 2000 4.31 0.34 8.66% 8625 8.735 17470 -50.6% 5.9%
AVIR 737 15.13 -1.00 -6.20% 11147 27.88 20544 -45.7% 7.6%
LGNDW 3000 2.38 0.13 5.56% 7125 8.75 26250 -72.9% 4.8%




STOCK ______ ______ ______ ______ 146968 183442 -19.9% 100.0%
SHORT SALE CREDIT ______ ______
MARGIN MTCE. EQUITY 37.9% MIN 30% (86845)
BUYING POWER $ ______ -33847
EQUITY (NAV) ______ ______ ______ 60123 100000 -39.9%


^IXB INDEX 305.72 6.81 2.28% 302.42 1.1%


NOTES: OPEN orders subject to available buying power---
Open limit sell order, 260 shrs GENZ @ $35