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


To: MisterED who wrote (6008)3/20/1998 7:22:00 AM
From: blankmind  Respond to of 23519
 
Possible impact on Vivus's earnings due to MCA approval:

1. Inventory on 12/31/97 - $9.1 mill + approx 2.0 mill of more at risk product produced thru 3/18/98 = $11.1 mill

2. If 100% of the $11.1 mill shipped to the U.K.

3. Profit margin of 30%

4. $3.3 mill dollars to Vivus' bottom line for this quarter.

Question: is it possible Vivus may actually turn in a profitable quarter? After all, with only 35 mill shs o/s - $3.3 mill divided by 35 mill = 9.4 cents a share.



To: MisterED who wrote (6008)3/20/1998 8:43:00 AM
From: BigKNY3  Respond to of 23519
 
Mister ED <<BigKNY, what is a User Fee Agreement? If FDA does not preannounce any approvals, how come this UFA will tell
you the approval will come in March? Yahoo says Viagra
is not on the list. Who should we believe>>

Mr Ed. In 1992, the FDA and the pharmaceutical industry reached an agreement called the Prescription Drug User Fee Act. Under this agreement, the pharmaceutical industry agreed to support the FDA with funds to pay for additional FDA staff. In exchange the FDA agreed to report the results of their NDA reviews within 6 months of the submission dates for "priority" drugs and within 12 months for "standard" drugs.

Traditionally, the FDA waits until the last week, and , usually, the last day of these 6 month or 12 month reviews to make their announcements. If these reviews are due on March 30th, the FDA will not announce the results in early March or mid March. Any list posted on the Internet will include only those drug approvals that have already been announced.

Here is an excellent FDA Website that explains the "how the FDA Approves New Drugs".http://www.fda.gov/fdac/special/newdrug/benefits.html

Good investing!

BigKNY3



To: MisterED who wrote (6008)3/20/1998 9:09:00 AM
From: BigKNY3  Read Replies (2) | Respond to of 23519
 
Mr.Ed Here is a link to the FDA New Drug Approval Page. It includes all products approved through March 19, 1998 and will be updated throughout the month. fda.gov

Good investing!

BigKNY3