Lets get to know IRONWOOD- the goal is not high- 3 good poops a week. But if you have IBD.... NEW ORLEANS -- An investigational drug to relieve chronic constipation was effective and caused no unexpected safety issues in two phase III trials, researchers said here. Linaclotide, a chloride channel activator that boosts intestinal fluid secretion, significantly increased the number and quality of spontaneous bowel movements in patients who had been almost completely reliant on laxatives, according to Anthony Lembo, MD, of Beth Israel Deaconess Medical Center in Boston. Both trials "met their primary efficacy endpoint," he told attendees here at Digestive Disease Week, with significant improvement in every prespecified secondary endpoint compared with baseline and with placebo. The only downside: the drug caused diarrhea in about 15% of patients, with 4% discontinuing treatment as a result. Linaclotide is a guanylate cyclase-C receptor agonist, promoting activation of the CFTR chloride channel. In animal models, the agent increased intestinal transit times and stopped visceral pain signaling, Lembo said. At DDW 2008 in San Diego, he reported favorable results from a phase IIb study that paved the way for the trials presented here. These were two nearly identical 12-week trials, each of which enrolled more than 600 patients (1,272 total). Both tested two doses of linaclotide, 133 and 266 μg once daily, and placebo. All results were based on the intent-to-treat population. The only difference between the studies was that one also included an extra, blinded period in which patients on active drug were randomized either to stay on the same dose or to be switched to placebo for four weeks; patients in the original placebo group were all switched to high-dose linaclotide. The studies' primary efficacy measure was the percentage of patients having at least three complete spontaneous bowel movements (CSBMs) per week -- that is, those leaving patients without residual discomfort -- as well as an increase of one from baseline in the weekly CSBM count. A significant difference in responder rates between active drug and placebo was the studies' primary endpoint. Lembo said it was met in both trials. Response rates were 21.3% and 19.4% of patients on high-dose linaclotide in the two studies, compared with 6.0% and 3.3% for the placebo groups (P<0.0001 for both), according to Lembo. The lower linaclotide dose was almost as effective, with responder rates of 16.0% and 21.2% (P<0.01 and P<0.0001, respectively). Nearly 40% of patients on both linaclotide doses had increases of at least one CSBM/week from baseline, indicating that the requirement of at least three CSBMs/week was the more stringent in the primary endpoint. The drug appeared to be almost immediately effective. At baseline, the mean weekly CSBM count was about 0.3, with 70% of patients having a count of zero. By week two, the mean in the active-treatment groups had risen to 2.5, whereas in the placebo group it was about 0.8. During the four-week randomized withdrawal period in the study that included it, CSBM rates jumped from one to nearly three in the first week, while they dropped by about the same amount in the patients on linaclotide who were switched to placebo. Weekly rates of all spontaneous bowel movements, including those that left patients still feeling uncomfortable, increased from a mean of about two at baseline to more than five with both linaclotide doses in both studies. In the placebo groups, rates never reached three. Improvements were also seen in other efficacy measures, including stool consistency, severity of straining, overall constipation severity, and patient assessments of quality of life. Except for diarrhea, adverse effects were equally distributed between the placebo and linaclotide groups. Rates of serious adverse events ranged from 1% to 3%. Overall discontinuation rates in the studies were about 15%, of which approximately half were due to adverse effects. Spencer Dorn, MD, a gastroenterologist at the University of North Carolina in Chapel Hill, N.C., called the linaclotide data "very impressive." He said the drug would be "a welcome addition" to the sparse existing options for chronic constipation. Particularly appealing, Dorn said, was that linaclotide appeared to have faster onset than polyethylene glycol-based remedies and fewer side effects than more potent therapies. Linaclotide's manufacturer, Forest Laboratories, is also developing the drug for constipation-predominant irritable bowel syndrome. >> You will notice Forest Labs involvement I find that strange w/o buying in on the drug. For this reason and the ugly chart I did not take a full position. The Price targets are nice and high though albeit from underwriters...
-US linaclotide sales (just US) are pegged at a potential $2.4 billion by 2019! -IRONWOOD has $299 million in cash! Will complete year with at least $220 mil - IRONWOOD has groovy partners in India and China... folks if they get the ok from the FDA this could be huge. So far the only side effect is more direaha for 15 of the testees... - Price targets of 17, 18 & 24. - I'm in that last camp. - Along with Wellington 17%! -Prudential 12% -Jennison Assoc? 10.4% -Field Corp? 9% -Putnam (again lets just hope they don't have one bad analyst) 9% -Adage capital (big NY hedge fund I think not sure) 4.8% -Stoney 1000 shares (hey that gets me into the meeting!)
Three good poops a WEEK??? Holy crap (pun intended)! And that's a GOAL? Here's the cheapest option there is and guaranteed to work within 3 days, providing 2-3 good poops a day: 1. Go through your pantry, cupboards and refrigerator and remove all processed foods, refined foods and animal-based foods (meats, cheeses, milk, etc.). 2. Replace all the crap you removed with whole foods only: grains, beans, nuts, seeds, whole grain cereals and pasta, fruits and vegetables. 3. Eat these foods that nature intended. 4. Poop with gusto as nature intended and never worry about constipation again. Oh...wait...then these companies wouldn't have anything to sell and we wouldn't be able to trade their stocks. Never mind
doji what would you do for tingling lower extremities. That's my problem now kind of working it's way up my legs and some loss of sensitivity in my hands. Trying not to go on the internet for the answer cause then they will try and get me into a Lupis test trial or something... I have White Coat Syndrome which is ironic for how into the drugs I am on an investing level. Might be a lesson there but I'm too drunk now to realize it. Standard mantra for a good poop is really greens salad. You can eat like a normal man and eat salad and get away with a lot. The processed food argument leads to weight control more than anything else. But it's a reality-- Live in Spain eat as late as you want, drink as much as you want and... you won't get fat. It's all so darn clean-- the food just slips out of you... My Cat back in the old days Elvis he got IBD. This is a bAD disease folks. No joke. Imagine a poor old man already wasting away just everything in and then out like a juicer. Well this cat he defiled my office in a way i am having trouble telling you now. I used to sit there with my rejection slips all around me (writer at the time) and be stinking in a room full of black juice everywhere; in the cracks of the wood, on the wall, on the art, on the chair... it was a nightmare and i would clean and clean and clean that poor kitties box cause once he put about three in there he was off to other places to discharge and the smell was so freeakin foul it's all coming back now Doji oh why did you bring this up? I had to throw out my Buck Rodgers collection that was worth a pretty penny. My dear Elvis... well we really struggled with the IBD and I ended up throwing out this ugly chair too, all painted these various bright garish colors that I hated anyway. Elvis had made most of the colors brown. I couldn't take the smell. During the height of the downturn my mother said to me " at least you have the chair "... turned out it was worth ten grand no one ever told me... ugliest thing you ever saw modernest... well I just put it out on 20th street and eighth avenue and made some antique dealer very very happy.~si
I only trade futures and yet I always read your posts. But, if you use the term "cats" again, I will start to think you may be Incy. I sincerely hope not, I really like your commentary.
http://www.karenhurd.com/concern_migraines.html _____ white coat it says is high blood pressure caused by occasional consricting viens or blood cells,the article on migraines deals with a similar problem
Not much to do today the only opportunity that presented itself was to fill in the rest of HTM @ 93 cents so our cost is between that and I forget where we got the first lot- just under a dollar. Now if Obama tonight lays out a clear plan for nat gas & other alt energies we should get a real nice response tomorrow. Quite frankly Geo Thermal is now passing solar in my view as most promising and cost effective. Behind the scenes Alaska just did some political opening up of geo thermal and HTM has two projects to start and ORA has upped it's new projects - the time is now for geo thermal. I'm sure there is a pump maker we could look into I seem to remember a stk that did that but also had a big fert side, man what was that name?? LXU that's it! Ha the old stoned one cxan stil do it... think that is.. they have a weird symbol LSB or something no it's LXU and the company is arrrrg oh forget it. lets stick with US Geo. This loan they look to be sealing up with the gov is a real sweet set up... lower than low interest and off we go income streams galore. I would like to get at the fine print of that offer- whether there are any caps on profit or %'s of profit that might have to go the Gov way but for now no one knows that... this stck is going to move towards $3. A name I follow is PPO. To be honest I follow it just because it moves around quite quickly, if you catch it right you make a lot of money. Let's watch PPO as Needham did an upgrade w a PT of $28. China trans Info CTFO-- This is a company that sits at a crossroads chart wise. It's got several levels to overcome above it. In it's favor is the fact that they have record revs and are way over sold. They work with the cities in China to regulate traffic flow and have a fleet of taxis with GPS for road reports and a web site and they just started an ez pass sort of set up electronic payments for freeways-- they do it with antennas and ding you at full speed. Pretty cool co. Watch List it. Adam F at the street.com is usually very tough on the junior bios he did say today that for an under $5 stk ZIOP had the best #'s he saw at ASCO and it is true we have several catalysts in July... so it's just a mater of time. Get on board now. The ZIOP train is going to leave the station. I'm sure of it. I think. YOU KNOW WHAT? As I'm typing here on my damn lap (desk comes thursday!!!) I'm co toggiling over to yahoo Finance and the company IS LSB INDUSTRIES WITH THE SYMBOL OF LXU.... DAMMIT! It looks good up nice today 86 cents 5% this is the geo thermal pump play! This will be the buy tomorrow as most of the early attention goes to Westport and gas Index funds and HTM.... the pumps... the reason I have not bought back into this company is they had the very cyclical fertilizer side. I made money once on them and then sat flat for a long time so a little TA work in the morning and OBV volume analysis should let us know if this is the way to go. If not we always have the PPO. ~ stoney ~stoney
What you are encountering more and more is well understood. Obviously you could avoid it by taking care of two things: your body and your mind. Donna covered your body quite well. So, if you are able you need to begin to read about how your mind works and how mistreating it causes physiological problems. You are experiencing the Bohr Syndrome. the stress you create by your increasing incoherence has the consequence of oxygen deprivation in your brain. you are now reaching a level of deprivation that is 30% below what your brain wants and now NEEDS. As you see this is a cummulative situation that is caused by your decision to end your hiatus. To train yorself out of your currnt behavior, you have to become mindful. See Zinn who enjoying his 30 aniversary of "mindfulness". Most people like you have not done meditation so you have not expereinced the symptoms of coherence, especially while doing research or offering advice about the future. as a substitute for learning about coherence, wire yourself into a monitor called an EMwave PC. You will see clearly you are out of control in no time flat. As the Bohr Syndrome becomes more and more pronounced you will notice more and more symptoms. Change your ways.