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


To: Sycamore who wrote (5734)3/3/1998 1:01:00 AM
From: BigKNY3  Read Replies (1) | Respond to of 23519
 
Sycamore <<BigKNY3,Good thinking. How about giving us another PFE stock prediction also just in case the FDA rejects Viagra or that an approval is delayed, say 6-18 months or more.>>

Sycamore: To best guess your question, it is first useful to review some facts and probabilities:

-95% of all NDAs filed are approved by the FDA

-To date, 100% of all completed priority reviewed NDAs have been approved by the FDA within 4-8 months of their submission dates. (Under the User Fee Agreement, the 6 month clock does not officially start until the FDA accepts the NDA filing + 60 days. However, the FDA usually tries to respond within 6 months of the NDA submission date.)

-In a PFE 1/22/98 press release, it was implied that the NDA submission was moving along. "Approval of Viagra could come soon, the company said, noting that the NDA was filed in September 1997, and FDA has granted it priority review."

If for some reason, there is a delay in the approval of Viagra, I would guess PFE would short-term correct over a one week period by 10 to 20% similar to the short-term impact that Rezulin concerns had on WLA.

I agree with others on this Board that it probably is in VVUSers' best interest that this approval come sooner rather than later.

Good investing!

BigKNY3