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Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?

To: mrnaive who wrote (639)	12/1/1998 12:06:00 PM
From: Dan Spillane	Read Replies (1) \| Respond to of 2539

There was already a negative news item coming out of the meeting, but at the same time we don't know what the rest of discussion is focusing on. I'm not surprised to see something bad come out of this, there is a lot of "influence" by other drug companies who don't want to see Monsanto, Pfizer, and Merck come out with popular new drugs. I would however like to see the rest of the story come out; i.e., the news isn't reporting the positive points under discussion. In other words, this one guy isn't the panel. I'm a bit suspicious of this kind of "partial news". Also, notice that Merck stock isn't moving much, which you would expect if Cox-2s future was in question. I guess we will have to wait for the actual decision. Headline: Searle (NYSE:MTC) drug fails pain standard-FDA expert ====================================================================== SILVER SPRING, Md., Dec 1 (Reuters) - Monsanto unit G.D. Searle ran into an unexpected bump on Tuesday in a Food and Drug Administration advisory panel meeting on the approval of its new analgesic Celebrex. An FDA official told the meeting that Celebrex (celecoxib) did not meet all the usual requirements for pain management. "We believe that celecoxib at this time has not yet met the requirements for critical management of acute pain," Mordechai Averbuch, a medical officer at the FDA told the panel meeting. Averbuch said the FDA usually requires two separate models that show an analgesic can reduce pain. He said that the drug was not superior to placebo in some studies, including two studies of knee pain in osteoarthritis patients. The panel is hearing evidence on Celebrex, the first of a new class of painkillers known as COX-2 inhibitors. The company has said several trials have shown it works as well as current painkillers without the side effects. The panel will vote on whether to recommend U.S. marketing approval of Celebrex later on Tuesday. The FDA is not bound by the advice of its advisory panels, but usually follows it. 898-8383, washington.economic.newsroom@reuters.com)) Copyright 1998, Reuters News Service