Cilansetron likely delayed

Sage,Remeron is an anti-depressant that also has 5-HT3 antagonist properties which make it similar in that respect to cilansetron and Lotronex. Take a look at the thread I started on it. Kath M. and Nath are longtime members of this board and gave me lots of useful info on it. With regard to my last post, I want to make clear just how hard Solvay's stock got hit today. It lost about 7% of its total worth in the last half hour of trading. The post about the delay on that Solvay board appeared two hours later. The connection to me seems unavoidable. I realize that I have made predictions about this drug based on what I thought was reliable information that never came true, and I would never in my life be so glad to be wrong about something as I would about this. It could be just that the FDA is taking more time to review the drug, because it caught so much flak for speedy reviews in the past. But the truth is I have no idea what exactly is going on (although the fact that the FDA at least has serious concerns about the drug's safety is clearly what is behind this.) And the scandals at that agency which seemed to be abating slightly just a little while ago are now back with a vengeance since Pfizer announced today that it halted a Celebrex trial because the drug appeared just as dangerous as Vioxx. I am depressed.

I'll get to the significance of the picture above in a second, but first I'd like to share with you my thoughts about IBS!Having IBS for 12 years now, I've pretty much accepted the fact that I may never be totally IBS free my entire life. If there is one thing I've learned, it's not to put all your eggs in one basket. You need to be realistic about this condition, and unfortunately that means that IBS may be a "life long condition". The difficult part is making the best out of the hand you've been dealt. In my case that's easier said then done. I was very excited about the release of lotronex, and thought for sure that it would cure me, but that was not the case. Ever since then it's been cilansetron, going on about 2 years now of anticipation. If nothing else these drugs have given me hope and have kept me going. Now about the picture. That picture was taken on top of the Sydney Harbor Bridge in Australia of course. What is the significance of the photo you ask? Well, I was 22 and had been living with IBS for 6 years and had reached a point in my life where I had built up enough confidence to subject myself to a scary climb with no bathroom available for 2 hours and meanwhile being tethered to a bridge. A few close calls since then have shattered my confidence and I've been slowly trying to work my way back up to being able to do something like that again. I guess my point is that there's no need to apologize for misinterpreting Solvay's stock information, we all want Cilansetron to work just as much as you, and we are all excited to here any news about it, good or bad. It's what gives us hope and keeps us motivated.

Solvay Pharmaceuticals, Inc. Announces 90-Day Extension of FDA Review of the New Drug Application for Cilansetron for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)- Joint FDA Advisory Committee Meeting Expected - MARIETTA, Ga., Dec. 20 /PRNewswire/ -- Solvay Pharmaceuticals, Inc.announced today that the U.S. Food and Drug Administration (FDA) has extendedits review of the cilansetron new drug application (NDA). The reviewcompletion date, previously set for January 1, 2005, is now April 1, 2005.Cilansetron is expected to be discussed at a joint Gastrointestinal and DrugSafety and Risk Management Advisory Committee. Solvay Pharmaceuticals isseeking approval to market cilansetron, an investigational 5-HT3 receptorantagonist being studied for the treatment of IBS-D in men and women, andexpects to launch the product in the U.S. shortly following approval in 2005. "We continue to work closely with the FDA as they complete the reviewprocess for cilansetron," said Dr. Harold Shlevin, Solvay Pharmaceuticals,Inc. President and CEO. Solvay Pharmaceuticals' NDA submission includes a comprehensiveCilansetron Appropriate Use Program that was created through a collaborationof physicians, pharmacists, patients, and risk minimization experts andincludes an array of interrelated educational tools and specific promotionalstrategies, designed to facilitate access to cilansetron for the appropriatepatient. Solvay Pharmaceuticals, Inc. (http://www.solvaypharmaceuticals-us.com) ofMarietta, Georgia (USA), is a research-driven pharmaceutical company thatseeks to fulfill unmet medical needs in the therapeutic areas of cardiology,gastroenterology, mental health, women's health and a select group ofspecialized markets including men's health. It is a part of the global SolvayPharmaceuticals organization whose core activities consist of discovering,developing and manufacturing medicines for human use. Solvay Pharmaceuticals,Inc. is a subsidiary corporation of the worldwide Solvay Group of chemical andpharmaceutical companies headquartered in Brussels, Belgium.SOURCE Solvay Pharmaceuticals, Inc.