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

To: blankmind who wrote (4961)	1/24/1998 11:24:00 AM
From: DR. BOND	Read Replies (2) \| Respond to of 23519

BlankO......Would it be possible for YOU to attend the VVUS OPEN HOUSE at the NEW facility on Jan 30th and report back to this thread your findings? DB

To: blankmind who wrote (4961)	1/24/1998 11:35:00 PM
From: MissLil	Respond to of 23519

-- MissLil: re: FDA issues 1. How do you reconcile the following: a. Viagra's studies haven't been widely published & peer reviewed. Hence, how would the FDA know the safety and effectiveness of Viagra? b. Pfizer's belief that the FDA will issue approval this year to Viagra. 2. And yes - you & all VVUS posters are welcome to stay at my house and make a midnight run with me to the plants in Lakewood, NJ. Out. Answers: 1a: Studies submitted to the FDA are not necessarily published, although they frequently are published eventually (although not necessarily prior to approval.) It seems that it would be better for the company to have the studies published before approval to get the PR going, but what do I know. Sometimes preliminary results are presented at medical conferences although there are some constraints on that. 1b. Pfizer obviously knows when they submitted the application. It's difficult to miss 40 volumes of material, submitted in triplicate, especially if you have to prepare it. However, the actual date of submission and even the fact that an application has been submitted is confidential and it is illegal and prosecutable (I think) for an FDA employee to reveal the existence of such an application. Pfizer has also probably had meetings with FDA officials and gotten a sense of whether the application would be approved. They also know how good (or bad) their data is. A product that has a significant clinical benefit or for which there are limited therapeutic options may qualify for an expedited review, in which case the FDA will review the application in six months. When I read the Newsweek article, I read between the lines that Pfizer had submitted the application, it had been accepted for review (i.e. all the parts were in) and that it had probably been approved for expedited review. This is all a guess however and I would really like a more authoritative opinion. For instance, has PFE made any public statements regarding the application? 2. Thanks for the welcome. I think a tailgate party at midnight in the parking lot would be appropriate. Maybe we could bring snacks for the hard-working factory folk?