I figured last night, but knowing the depth of the conversation, I'm sure it will take him a day or two to put it together. Hope not too long. :-)
Horst sounded like a bumbling idiot. He has no business speaking to cameras and the press. Is there no one else on staff that can act as the speaker? Zerbe needs to take the approach when talking that less is more. The guy interviewing him had to cut him off several times because he was just rambling. He has a great opportunity to create investor interest and he blows it, imo.
Stock, those are some good questions. I'm interested if you ever got a response or acknowledgement of some of your questions/ points of emphasis, especially the one regarding IONSYS submitting. Not being familiar with that company, Is it comparing apples and apples? Were they successful in getting approved?
With 951 patients in the phase II trial alone for CIC, That provides a pretty good indicator. This is unique as their phase II was impressively and uniquely large. Three test results subjecting over 1,500 subjects to plecanatide have all showed positive feedback.
Good question. Don't know. Just know that the trials have been designed by the same guy who designed the trials for Ironwood, which should be good news. Considering they work very similarly and Plecanatide has been tested on over 1,500 subjects in it's studies of IBS, CIC, and OIC, that all seem to show similar type results, my jaw would drop and I may throw my computer if results are not good.
Though nothing is certain, the very high number of subjects in previous trials bodes well for a positive outcome. That and the tests are being conducted by the same individual that got Linzness through phase III trials.
all with similar results and treating IBS, CIC, and OIC. I really can't imagine results that could not fulfill the objectives of the study. Hope we're right.
Jim, I appreciate your efforts. Can you give me an idea of your background? You appear to be respected on this board. Thanks!
Wow! Just saw this article on Yahoo news.
(Reuters Health) – The number of people going to U.S. emergency rooms for constipation has been going up, and so has the cost of those visits, which reached $1.6 billion in 2011, according to a new study.
“Constipation is often thought of as not a serious disease – particularly among doctors. Patients complain about it but it’s often not thought of as being medically that relevant,” said Dr. Anthony Lembo, the study’s senior author from Beth Israel Deaconess Medical Center in Boston.
His team’s previous research found that a large number of people were being hospitalized for constipation, and that led them to examine ER visits for the same issue, Lembo told Reuters Health in a phone interview.
“A lot of these people don’t end up getting admitted, obviously, but they’re seen in the ER,” he said.
Constipation affects an estimated 12 to 19 percent of the U.S. population, Lembo and colleagues write in The American Journal of Gastroenterology. Symptoms include having fewer than three bowel movements a week, or hard, dry and small bowel movements that are painful or difficult to pass.
Using data from more than 950 U.S. hospitals, the researchers estimated that there were 497,034 ER visits for constipation during 2006. In 2011, there were 703,391 visits, an increase of about 42 percent.
The increase in ER visits for constipation is greater than the 22 percent increase in overall ER visits during that time, the researchers write.
Infants and the elderly were most likely to wind up in the ER for constipation, which mirrors the condition’s prevalence in general, Lembo said.
Accounting for inflation, the cost of those visits also rose by about 56 percent per patient, from about $1,500 in 2006 to about $2,300 in 2011.
About $1.6 billion was spent on ER care for constipation in 2011, according to those numbers.
The study can’t explain why people come to the ER with constipation, Lembo said. They may have symptoms such as severe abdominal pain, he said.
His team thinks there are probably several reasons why visits for constipation increased, including an increase in the number of people on government-funded insurance.
Those people may be more likely to seek treatment at an ER and less likely to purchase over-the-counter treatments for constipation, the researchers write.
The new study highlights that constipation is a growing healthcare issue in the U.S., said Dr. JoAnn Kwah, a gastroenterologist at Montefiore Medical Center in Bronx, New York.
“One important thing to know about constipation is that it can be due to many different underlying causes so in order to minimize developing this disease, it would be important to know why it's occurring in the first place,” she told Reuters Health in an email.
Health conditions or medications may cause constipation, said Kwah, who wasn’t involved with the new study. People having issues with constipation should review their medication list with their physician, she said.
Constipation can also be caused by a lack of dietary fiber and Kwah suggests people keep up with the recommended fiber intake of 25 to 30 grams a day.
“This can be done by increasing the amounts of fruits and vegetables in one's diet, as well as supplementing one's diet with fiber supplements available from local pharmacies,” she said.
Though I completely agree with your statement and response, I think having a phase II with over 1,000 patients bodes well for the success of the phase III trial.
Stock and rogo, what do you feel the "risk assessment" is then? I felt the bench testing went well beyond the error rate the FDA was looking for. Very frustrating all around, that's for sure. The lack of clarity that is being communicated and the apparent lack of clarity the company has from the FDA and the FDA from the company make this sums up the poor communication all around.
Either you are a hopeless optimist, you know something others don't, or you are ridiculously ignorant. Though they have a temporary CEO, what makes you think they are going to replace him anytime soon?
I think it's more political than anything. The pressures of more opium based painkillers on the market and the reluctance to contribute to potential abuse/selling could be an issue. As was pointed out in the presser by one of the board members from ACRX, there are many painkillers subscribed to a patient and they leave the hospital to do whatever they want with it. This is disseminated in a hospital setting and for only a limited time. Though I think the concerns can be answered, I feel the FDA is being a thorn in our sides for potentially misplaced tablets and the lack of supervision when the tablets are being administered.
I don't understand why ACRX couldn't proceed towards marketing with the idea that the drug would be delivered under the guidance and supervision of a nurse while they work out the details of independent use with the FDA?
I agree. With the number of patients involved in the phase II study being so impressively high and the results being so impressively good along with other results that show SP333 is just as good, it would be incredibly stupid to sell before results. I think when you have the results we have, you take a calculated much more minimal risk by waiting and selling at a higher price. It's not about being greedy, but confident with what has been shown in trials and the fact that Ironwood already has a very similar product that shows the proof of our concept, also.
With as many subjects that were in previous trials, it would be utterly shocking if results were not similar. I think that is what makes the company so intriguing is that the number of patients in their phase II studies were very large.