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


To: Little Gorilla who wrote (18601)2/9/1999 3:10:00 PM
From: DaiS  Read Replies (1) | Respond to of 23519
 
Jenny,

Possibly Greg meant that the phase III trials were carried out excluding certain categories of men, and that there is not good justification for this.

DaiS



To: Little Gorilla who wrote (18601)2/9/1999 3:26:00 PM
From: Little Gorilla  Respond to of 23519
 
To put this all in perspective:

There are 2,300,000 deaths in the U.S. annually.
The age-adjusted death rate is 491.6 per 100,000.
There are 733,834 deaths caused by heart disease annually.
The age-adjusted rate of deaths caused by heart disease is 135/100,000.
Heart disease is rated the #1 cause of death.
There are 22.3 million cases of heart disease reported annually.

From FDA (12/98):

"As with all approved drugs, there have been postmarketing reports of important side effects with <Viagra>. These have been reviewed carefully by FDA since <Viagra>'s approval in April l998. Although a causal relationship cannot be established from these reports, they are being mentioned in the labeling. FDA typically requires manufacturers to update their labeling with such information. It is important to note that the postmarketing reports involving <Viagra> constitute only a small fraction of the more than six million prescriptions written for this drug. FDA continues to believe <Viagra> is safe and effective if used according to the updated labeling."

"The labeling notes that it is not possible at present to determine whether the cardiovascular events are directly related to <Viagra>, to sexual activity, to the patient's underlying disease, or to a combination of these factors."