I am lovin this! Couldn't have happened to a bigger group of losers. Lol!
Anonymous
Guest
Anonymous
Guest
Anonymous
Guest
Re: Karma!!! Can you imagine how many of us are enjoying this!!! They so deserve it!
UPDATE: Salix Sees Regulatory Delay In Widening Use Of Xifaxan
Article
EmailPrinter
FriendlyShare:
facebook
↓ More You can achieve relief of IBS symptoms even better with Align!!!
Text
(Updates to add details, background)
By Peter Loftus
Of DOW JONES NEWSWIRES
Salix Pharmaceuticals Inc. (SLXP) expects the U.S. Food and Drug Administration to decline to approve the company's bid to widen the uses for its gastrointestinal antibiotic Xifaxan because the regulator wants more information.
Shares of Salix plunged $9.40, or 23%, to $32.05 Thursday, as investors reduced expectations of near-term sales growth in light of the regulatory setback.
Xifaxan is currently approved to treat travelers' diarrhea and to reduce the risk of recurrence of hepatic encephalopathy. The drug had $167.4 million in sales for the first nine months of 2010, or 76% of total company sales; full-year 2010 figures haven't been reported yet.
Last year, the company applied for FDA approval to market the drug to treat non-constipation irritable bowel syndrome and IBS-related bloating. The company had hoped for FDA approval by a target date of March 7, and analysts were expecting the approval to help lift Xifaxan sales.
A company-funded clinical trial showed that the drug provided significant relief of IBS symptoms versus a placebo, according to results published in The New England Journal of Medicine last month.
But Salix said Thursday that based on a telephone conversation with FDA officials Wednesday evening, the company now expects the agency to send a so-called "complete response letter" by March 7. The agency sends such letters when it's not ready to approve drug applications.
Salix said the FDA wants additional information regarding "retreatment." Salix spokesman Michael Freeman said IBS is a chronic condition, and the FDA wants to know how Xifaxan would perform in patients who experience a recurrence of symptoms. Certain clinical data supporting Salix's IBS application only tracked patients for 10 weeks following a 2-week treatment regimen of Xifaxan.
"It seems now FDA has taken a conservative stance with the application," BMO Capital Markets analyst Robert Hazlett wrote in a research note to clients.
Analysts said it's now possible the FDA would delay final approval of the application for as much as two to three years. The company may have to run an additional clinical trial to generate the retreatment data.
Freeman said it was too soon to say whether the company will run an additional trial. Salix, of Raleigh, N.C., said it will consider its next steps following receipt of the FDA's complete response letter.
Freeman said the company's business remained strong despite the setback, and that it's annualized run rate of revenue for currently marketed products is about $476 million. The company also predicts peak annual sales of $1.2 billion for its current products, reflecting uses already approved by the FDA.
-By Peter Loftus, Dow Jones Newswires; +1-215-656-8289
UPDATE: Salix Sees Regulatory Delay In Widening Use Of Xifaxan
Article
EmailPrinter
FriendlyShare:
↓ More You can achieve relief of IBS symptoms even better with Align!!!
Text
(Updates to add details, background)
By Peter Loftus
Of DOW JONES NEWSWIRES
Salix Pharmaceuticals Inc. (SLXP) expects the U.S. Food and Drug Administration to decline to approve the company's bid to widen the uses for its gastrointestinal antibiotic Xifaxan because the regulator wants more information.
Shares of Salix plunged $9.40, or 23%, to $32.05 Thursday, as investors reduced expectations of near-term sales growth in light of the regulatory setback.
Xifaxan is currently approved to treat travelers' diarrhea and to reduce the risk of recurrence of hepatic encephalopathy. The drug had $167.4 million in sales for the first nine months of 2010, or 76% of total company sales; full-year 2010 figures haven't been reported yet.
Last year, the company applied for FDA approval to market the drug to treat non-constipation irritable bowel syndrome and IBS-related bloating. The company had hoped for FDA approval by a target date of March 7, and analysts were expecting the approval to help lift Xifaxan sales.
A company-funded clinical trial showed that the drug provided significant relief of IBS symptoms versus a placebo, according to results published in The New England Journal of Medicine last month.
But Salix said Thursday that based on a telephone conversation with FDA officials Wednesday evening, the company now expects the agency to send a so-called "complete response letter" by March 7. The agency sends such letters when it's not ready to approve drug applications.
Salix said the FDA wants additional information regarding "retreatment." Salix spokesman Michael Freeman said IBS is a chronic condition, and the FDA wants to know how Xifaxan would perform in patients who experience a recurrence of symptoms. Certain clinical data supporting Salix's IBS application only tracked patients for 10 weeks following a 2-week treatment regimen of Xifaxan.
"It seems now FDA has taken a conservative stance with the application," BMO Capital Markets analyst Robert Hazlett wrote in a research note to clients.
Analysts said it's now possible the FDA would delay final approval of the application for as much as two to three years. The company may have to run an additional clinical trial to generate the retreatment data.
Freeman said it was too soon to say whether the company will run an additional trial. Salix, of Raleigh, N.C., said it will consider its next steps following receipt of the FDA's complete response letter.
Freeman said the company's business remained strong despite the setback, and that it's annualized run rate of revenue for currently marketed products is about $476 million. The company also predicts peak annual sales of $1.2 billion for its current products, reflecting uses already approved by the FDA.
-By Peter Loftus, Dow Jones Newswires; +1-215-656-8289
Anonymous
Guest
Anonymous
Guest
How will this impact the expansion currently going on (Hospital division)?
Anonymous
Guest
Anonymous
Guest
i bet c.l is hunkered down with a big bucket of popeyes chicken to ease the pain....this is exactly what they deserve!
Anonymous
Guest
Anonymous
Guest
This is the type of karma that happens when you treat people like shit despite all the hard work they put into their career. Salix is an awful, awful place to be as evident by the high turnover.
This news makes me so happy! Karma is right!!!!!!!!
This news makes me so happy! Karma is right!!!!!!!!
Anonymous
Guest
Anonymous
Guest
This is the type of karma that happens when you treat people like shit despite all the hard work they put into their career. Salix is an awful, awful place to be as evident by the high turnover.
This news makes me so happy! Karma is right!!!!!!!!
What type of "karma happens" when one gloats in the misfortunes of others? I'm happy for you that this setback has brought some joy into your empty, miserable, resentful life.
Anonymous
Guest
Anonymous
Guest
What type of "karma happens" when one gloats in the misfortunes of others? I'm happy for you that this setback has brought some joy into your empty, miserable, resentful life.
Oh contraire, My life WAS MISERABLE and I felt totally resentful when I had to work for this abysmal bunch of jerks. As soon as I left, the light came back on. I really feel sorry for the sales people who have to stay here.
Anonymous
Guest
Anonymous
Guest
How will this impact the expansion currently going on (Hospital division)?
You can kiss that goodbye! What are you going to sell in the hospital, bowel preps?
Anonymous
Guest
Anonymous
Guest
What type of "karma happens" when one gloats in the misfortunes of others? I'm happy for you that this setback has brought some joy into your empty, miserable, resentful life.
Ahhhh, you poor little wussy. Go run along and beg doctors to sell your overpriced ass cleaner lol. Make sure your car is clean because your used car salesman manager will be riding with you again for the 3rd time this month. Saylicks is a joke of a "company."
Anonymous
Guest
Anonymous
Guest
our lawyers need to drink a gallon of our ass cleaner solution and leave, they fucked up the application to the FDA, heard it directly from Reg. Affairs, they tried to do it right, but the lawyers interfered.
Anonymous
Guest
Anonymous
Guest
doubt it, the lawyers dont review NDA applications.
Anonymous
Guest
Anonymous
Guest
You can kiss that goodbye! What are you going to sell in the hospital, bowel preps?
You are a fucking moron and thank God we don't have someone with your intellect still selling for us anymore. Tell me, genius, how much IBS do you think is treated in the hospital setting? Now get back in your big pharmacy pod where nobody will notice how clueless you are.
Anonymous
Guest
Anonymous
Guest
Honey I left saylicks years ago for biotech. Never looked back. Made over 250k last year. What did you make? Rode with my boss twice last year? How many times did you ride with your boss?
Now run along and sell your ass cleaners lol.
Now run along and sell your ass cleaners lol.
Anonymous
Guest
Anonymous
Guest
Honey I left saylicks years ago for biotech. Never looked back. Made over 250k last year. What did you make? Rode with my boss twice last year? How many times did you ride with your boss?
Now run along and sell your ass cleaners lol.
With procedees from sale of stock, I made significantly more than that, bitch. And I am positive you are lying about earnings. If you were doing so well, you wouldn't be so obsessed with Salix. You just cannot get over what a miserable failure you were here.
Anonymous
Guest
Anonymous
Guest
You can kiss that goodbye! What are you going to sell in the hospital, bowel preps?
Lol, ass cleaners.