I am in this thing, also, but come on, that's not responsible investing. Not sure if serious, but just trying to prevent others from making quick decisions on investments that aren't financially sensible. Though this stock has a lot going for it and I am cautiously optimistic, I've been through these types of things enough to no that nothing is a sure thing. Only invest what you can afford to lose.
"ARX-04 or placebo will be administered by site staff as requested by the patient but no more than once per hour." Being that the drug is already approved, I don't understand the rules as to why we have to do a trial for this. The drug's safety and efficacy compared to placebo are already acceptable. Just doesn't make sense to me. Makes me question whether Acrx-04 should have been developed first.
researcher, wouldn't it seem logical to have management from Grunenthal consult with and take charge on making sure that things are in order? I know that if my career relied on an approval and I was denied once, I would reaffirm everything that I just read in a CRL. Their conference call sounded like they had minimal discussions with the FDA and went primarily off their interpretation of the CRL. To me, that is a huge oversight.
The biggest problem I have with that, however, is that you are still providing those tablets in a secured and structured setting. Unlike drugs like Zohydro that allow a person to disseminate and abuse however they feel like it, this drug is in a controlled environment, disseminated at a predetermined time interval and for a limited time to a person who is in obvious pain. There is a HUGE double standard here that makes no sense.
1st thing I would remind you is that it is impossible to predict how incompetent these guys have been. The fact that they mentioned that they simply based their response to the FDA strictly off the CRL without any sort of confirmation or consultation with them throughout the process, tells me they are very good about making sure all of their bases are covered.
Of course, I could be wrong, but when I heard the following in the conference, I felt there needed to be a better collaboration with the FDA. I don't know, I just feel like there were stones left unturned.
Boris Peaker - Cowen & Co.
And this is my last question, I guess since your last communication or how many communications have you had with the FDA since the CRO, and was there something that's submitted that you think that could have triggered their thought process on bringing new study as part of that communication?
Tim Morris - CFO
Obviously the primary communication was the Type-A meeting that we held in September other than that, we've had backwards and forwards on protocols mostly because there were four actually, but I'm not sure we had any other formal meetings with the agency other than that Type-A meeting.
Does it matter at all that the mechanical device was pushing the button instead of humans? I realize that they said they got it approved by the FDA, but again, I question the clear communication.
Tim Morris - CFO
Okay. So in the bench test what we’re doing is setting up devices on a mechanical jack, and instead of the patient's thumb pushing the dosing button, it’s actually a mechanical device pushing the dosing button with a thumb tag on that push while basically pushing the dosing button.
That's really the only difference.
"I own over 100,00 shares and want to know if this is a good investment." They had to have laughed at that one.
Pentech and Stillondgo bug the #$%$ out of me as I feel they are always trying to bash. This, however, is a valid point. Trust is broken and won't easily be restored.
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.
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.
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?
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?
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.
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.
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.