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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?


To: Mkilloran who wrote (17562)1/8/1999 6:06:00 PM
From: VLAD  Read Replies (1) | Respond to of 23519
 
martin,

There is only 2 things that are going to move this stock back into double digits in the short run.

1)A domestic partner who pays Vivus a nice upfront payment.

2)If 1) occurs then a committment by Vivus management to buy back more shares on the open market. BUT TO NOT DO IT IF THE PRICE OF THE STOCK MOVES BACK TO REASONABLE LEVELS. This IMO is the only thing that will break the will of the manipulators. They have to cover 7.5 million shares and the more cheap shares Vivus takes off the market the harder it is going to be to cover when some solid earnings numbers arrive.



To: Mkilloran who wrote (17562)1/9/1999 12:46:00 AM
From: Zebra 365  Read Replies (1) | Respond to of 23519
 
Clinton Seeks More Money for FDA

.c The Associated Press

By LAURAN NEERGAARD

WASHINGTON (AP) -- The Clinton administration is seeking to infuse more cash into the agency that monitors the safety of food and drugs because of worries it's losing the ability to fully safeguard Americans' health.

The Food and Drug Administration says it's $165 million in the hole because of six years of budgets that didn't keep up with inflation. It's short 500 employees, and needs more specialized scientists to evaluate increasingly complex therapies. Its inspectors can check the safety of only a fraction of medical and food factories every year. And its research, which helps ensure new products are safe, has been slashed.

"We cannot do everything that is expected of us," FDA Associate Commissioner Linda Suydam told industry lawyers recently, in an unusually stark admission.


But it's unclear if Congress, which has long battled the agency over issues such as tobacco, will go along.

Clinton officials say more FDA money is a priority this year, but won't yet give a total. The first chunk: An extra $30 million that would increase food safety by hiring 60 more inspectors and better monitoring foods imported from abroad.

The agency is responsible for $1 trillion in products -- from drugs, medical devices and donated blood to foods and cosmetics -- that Americans use daily.

Even as it sounds an alarm, the agency insists consumers shouldn't panic. It has reshuffled enough resources to deal with serious health threats and properly approve new medicines, its two top jobs.

But it has been under intense congressional pressure to approve new drugs faster. Consumer advocates charge that is dangerous and point to controversial drugs like the impotence pill Viagra, arguing it won approval with too little warning of deadly side effects.

In a new report to Congress, the FDA details numerous gaps in other duties, including inspecting manufacturing plants and monitoring drug side effects.


''The Congress and the American public have said they want smaller, more efficient government. I think the FDA has certainly recognized and responded to that,'' said Deputy Commissioner Michael Friedman, who ran the agency the last two years.

But with an increasing workload that demands ever more expertise, ''we face some really formidable challenges,'' he said.

An influential Republican lawmaker was more blunt: ''Let's face it, the FDA is underfunded,'' Sen. Orrin Hatch, R-Utah, said in a recent speech. ''The administration and indeed the Congress is going to have to take a hard look at what we are asking the FDA to do, and with what resources.''

Every year, the number of new products FDA evaluates rises by 12 percent. The products are getting more complex, including technologies like genetically engineered drugs. In recent years, threats such as new viruses and food poisonings have risen.

The agency's budget is $1.1 billion, up from $800 million in 1993. Six years of inflation and the increased workload mean the FDA actually has a $165 million shortfall, Friedman estimates.

Congress allows the agency to charge drug makers fees that hire reviewers of prescription medicines. Similar fees pay for quality inspections at mammography clinics.

But money for other areas has lagged: There are delays in reviewing new foods and cheaper generic drugs. An aging population is using more powerful drugs and medical devices, yet the FDA estimates it detects only 10 percent of injuries caused by improper use or unexpected side effects.

''One of the things sacrificed is the scientific expertise,'' Friedman added, as the agency struggles to recruit those trained in the newest technologies. New Commissioner Jane Henney has pledged to make rebuilding the science base a top priority.

And vaccine experts express frustration that scientific research has been slashed, saying the agency must find money to study an experimental new way of making vaccines -- by growing them in human tumor cells -- to make sure it's safe.

''We are all very worried about the financial structure'' of FDA, said Dr. Patricia Ferrieri of the University of Minnesota. ''The nation's health is the subject here that we're grappling with.''