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AP Blood Pressure Drug Approved Friday June 15, 6:44 pm ET Drug to Treat Rare High Blood Pressure Condition Approved
WASHINGTON (AP) -- Patients who suffer from a rare disease that causes continuous high blood pressure in the arteries of the lungs received a new treatment choice Friday.
The Food and Drug Administration said it approved Letairis to treat pulmonary arterial hypertension. The condition causes continuous high blood pressure in the arteries that carry oxygen-poor blood from the heart to the lungs. As the arteries narrow, the heart must pump harder, which weakens it with time. The disease affects about 100,000 people in the United States.
ADVERTISEMENT The drug, known generically as ambrisentan, is made by Gilead Sciences Inc., based in Foster City, Calif. The company said the drug would be available next week.
The drug comes with strong warnings as it may cause birth defects and shouldn't be used by women who are pregnant or may become pregnant. It also can cause liver damage. Patients taking the once-daily tablets must undergo monthly blood tests to check for injury to the liver, the FDA said.
A second pharmaceutical company, Encysive Pharmaceuticals Inc., was awaiting word on whether its drug to treat the same condition had been approved. The status of that drug, Thelin, or sitaxsentan sodium, wasn't immediately clear Friday. An FDA spokeswoman referred questions on the drug's status to the company. A spokesman said the Houston company had heard nothing.
Other approved medications to treat the condition include Tracleer and Revatio, a lower dose of the same key ingredient in the impotency pill Viagra.
Posts: 78 | From: Easton,Md | Registered: Mar 2007
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more like the powerhouse big boys always win (gilead) good thing I played this with free shares, I had a feeling lately something behind the scenes wasnt right
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
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if its in the ****ter monday, i will hold and hope. If I can sell for a small loss i will sell. The thing that bothers me is that they were banking on this drug for cash flow and now they may have to downsize the company. Its also discouraging this is the third rejection from FDA
Posts: 38 | Registered: May 2007
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Its over, Gild and Traceler drug will beat ENCY in price for their drug because they have cash. Encysive needed this one. Only hope is a buyout of rights for Thelin. Otherwise Im selling the rest of my free shares.
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
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So if you read my previous entries you know that I have always sold my pharms before FDA decisions. I have missed out on money that way, but I never lose money. I really believed ENCY would get approval on this one. Lesson learned, back to my old ways.
Posts: 124 | Registered: Oct 2006
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Does anybody think that it would be wise to try to buy up some of these cheap shares? I got caught with my hand in the cookie jar and now am stuck with this! I'm thinking of averaging down here!
Posts: 333 | From: Cullman, Al | Registered: Sep 2005
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quote:Originally posted by Bluemound_Freak: Does anybody think that it would be wise to try to buy up some of these cheap shares? I got caught with my hand in the cookie jar and now am stuck with this! I'm thinking of averaging down here!
You probably don't want to hear this, but I agree with 22, this thing is done. Time to focus on making that money back somewhere else.
Posts: 124 | Registered: Oct 2006
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quote:Originally posted by stocktrader22: Its over, Gild and Traceler drug will beat ENCY in price for their drug because they have cash. Encysive needed this one. Only hope is a buyout of rights for Thelin. Otherwise Im selling the rest of my free shares.
Hold that exit door open stock22, I'm right behind you.
Damage, yes. Not so bad though; it could be much worse for me. I fortunately sold a bunch Friday 4.52 because those wild daily swings really gave me bad karma about how this thing was being traded.
Well, good learning experience. I think I'm done with this company though, at least for a long while. I hope you guys made (it) out fairly unscathed.
Posts: 252 | From: WestCoast | Registered: Oct 2006
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Yeah, I got out this morning - basically broke even because I sold half on the "big" run. Hate I dumped early though, because I could have made a little more change now....but you never really know....could have kept on going.
-------------------- Study before you buy, Sell before you think about it.... Posts: 3903 | From: Gulf Coast | Registered: Jun 2006
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UP UP AND AWAY sorry for you who took a loss ! Going to explode on that big of a drop get in on these prices going back to 5 within a month good month holder.
quote: UP UP AND AWAY sorry for you who took a loss ! Going to explode on that big of a drop get in on these prices going back to 5 within a month good month holder.
lol, you serious?
Posts: 38 | Registered: May 2007
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quote:Originally posted by mikeo69: UP UP AND AWAY sorry for you who took a loss ! Going to explode on that big of a drop get in on these prices going back to 5 within a month good month holder.