Not safe at all. It does nothing to reduce heart attacks, strokes or other possible benefits. As a matter of fact it carries more risk than others.
VBLOC is totally safe compared to bariartic surgery of 1 death per 300 candidates and, benefits both hypertension and diebetic, two other huge markets.
It is clear that pills don't sell and explains why competition is hostile towards VBLOC. Adding a third pill to the market of a different color from ARNA, VVUS will not do much. People want safefy and black box scares the wits out of people.
I agree. Doctors first look out for their own self-interest and that is not to get sued. Secondly fat people have a host of medical issues already, add a dangerous pill and you might as well refer them to a funeral home.
I see pop on Orex and then selloff or, just selloff right away due to black box labelling plus 12 week restriction.
Don't forget to add the funeral expenses plus a long line of medical lawsuits requiring lawyer fees plus traumautized doctors who go bankrupt due to dangerous side effects....
If Doctors are not approving a safer ARNA pill, they will run from OREX pill.
If they sell 2 pills per year I would be surprised.
Who the heck would take this pill? Compare that with VBLOC with is about as safe as you can get. People WANT safety and these suicidal pills ain't going to do the job.
This tells us that FDA really needs solutions and VBLOC will easily be approved compared to this dangerous pill.
No one will be taking their pill which such severe side effects, black box warning and to be discontinued at 12 weeks if not more than 5% of weight is lost.
Here are side effects:
Patients using Contrave at the maintenance dose should be evaluated after 12 weeks to determine if the treatment is working. If a patient has not lost at least 5 percent of baseline body weight, Contrave should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Because it contains bupropion, Contrave has a boxed warning to alert health care professionals and patients to the increased risk of suicidal thoughts and behaviors associated with antidepressant drugs. The warning also notes that serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation.
Contrave can cause seizures and must not be used in patients who have seizure disorders. The risk of seizure is dose-related. Contrave should be discontinued and not restarted in patients who experience a seizure while being treated with Contrave.
Contrave can also raise blood pressure and heart rate and must not be used in patients with uncontrolled high blood pressure. The clinical significance of the increases in blood pressure and heart rate observed with Contrave treatment is unclear, especially for patients with heart-related and cerebrovascular (blood vessel dysfunction impacting the brain) disease, since patients with a history of heart attack or stroke in the previous six months, life-threatening arrhythmias, or congestive heart failure were excluded from the clinical trials. Blood pressure and pulse should be measured prior to starting the drug and should be monitored at regular intervals, particularly among patients with controlled high blood pressure prior to treatment.
Other products containing bupropion should not be taken along with Contrave. The drug should not be used in patients who have eating disorders (bulimia or anorexia nervosa). Contrave should also not be taken by patients who are using opioids or treatments for opioid dependence, or who are experiencing acute opiate withdrawal. Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates and antiepileptic drugs should not take Contrave. Women who are pregnant or trying to become pregnant should not take Contrave.
I heard that OREX will have FDA decision and, they are either going to REJECT or put strong labeling on pills as to be available only to monkeys since human trials was too risky.
I hope you are right, that vision scared the heck out of me.
Hopefully, it is the reverse, going to $ 20.
I had a vision that approval is imminent within days at most. What I saw was price plunge to 20 cents on stunning decision going against FDA Panel and requesting new testing on device as protocol was not properly drafted.
I was shocked seeing my investment plunge in price and my reaction was what surprised me. I quit the business I was in, left the office and began a new career in a totally different. In a way I felt freed from materialism.
This is a deja vu vision so I don`t know what to make of it.
DR. LERNER: Thanks. I'm Herb Lerner. I'm the Deputy Division
Director in the reviewing division.
I think your point is well taken. And we've all read that paper
over and over again. There's a little bit of a difference between an
endoscopic procedure and a surgical procedure. When we designed a lot of
these studies years ago, we didn't have much to go on. We had lap band
studies, and we extrapolated data to come up with what we thought were
If we had to do it over again and start another study today, it
would probably be different than what we did before. And you will be sort of
teased to answer that question yourselves in one of our Panel questions. So
it's an ongoing discussion here, but point well taken.
Based on census of 330 million USA citizens 75% are white so 248 million white folks.
Out of 248 million white folks there are more women than men due to war casulties, so 60% women, which totals 148 million women.
If we remove infants and children under 10 of 25 million you have 123 women of which per stats 66% are obese so 80 million patients.
So the pool available to ETRM with restrictive labeling meaning only women and, only those who are not undergoing MRI is 80 million.
Based on 100,000 patients per year, ETRM has enough work for 800 years.
There is a reason why protocol was skewed to women, as these stats will show that out of 10 women obese, all of them will seek either pills or surgery or whatever. Out of 50 obese men perhaps one will seek weight advice.
By the way, this is my prediction, FDA will REJECT or STALL OREX.
I can't believe how many people are responding to oozhee22 and are actually giving him attention. I would like to ask the board, is oozhee22 a voting member at FDA for ETRM? If not, then forget him and stop feeding a person whom has a track record of being wrong.
What matters is that FDA Panel voted 6 to 2 on benefit vs risk and this is new paradigm. It is true that tests were skewed with a more white female population and hence labeling may include only this market. This is really the only market which counts as men are not conscious of their looks as women are whom are the bulk of the market. That is why testing was skewed in that direction in the first place. Women care about their looks and they are constantly looking in the mirror; men look in the mirror once per year.
What matters is that the FDA Panel said that the 18 month data supports efficacy. What matters is that it is the FDA that requested for the 18 month data even though protocol was only for 12 months and, requested FDA Panel to consider 18 month data. What matters is that FDA Panel was even shown 24 month data with FDA blessings, prior to voting, which again is a green light from FDA.
What matters is that the FDA is working on labeling with ETRM which is often sign of approval. What matters is that most questions FDA had for ETRM were post approval ones. What matters is not limitation on labeling but size of this market from labeling. There are 200 million people obese, if we remove men and non causcian, you will still have 100 million people. There are more women than men since men are killed in wars.
What matters is what you think of the stock and not what oozhee22 thinks. How can you allow his opinion to influence you, he who has not the guts to buy one (1) single stock. Money talks, trash walks. Be smart.
He doesn't have to be directly on the payroll to accomplish this.
It can be done through a third party that hires him and he doesn't even know himself why he is to bash, all he is told is to keep price in check. Then a secret deal between Medtronic and third party, no apparent transactions except for envelops.
Remember this is Wall Street where there is dirty tactics all the time.
I don't see him bashing for 15 cents per post. I can't see him bashing for accumulation as this is going on for one (1) year now, way too long. I can't see him bashing because he is disgruntled employee because his research is too detailed and is done without emotion.
What is left than saying he is a madman, which apparently he is not.
I therefore have a very strong hunch, that he is paid through third party, to cast doubt to hold price in check until approval as there is interested acquirer who wants ETRM only on approval but is not ready to pay through the roof prices either.
That would surely motivate a person like oozhee22 to conduct detailed research, find papers, post numerous times, argue back and forth, make false allegations and so forth. It is like fighting a lawyer who is there to smudge ETRM, keep price low and, buyout price reasonable.
I will put out another theory out there for discussion. Perhaps oozhee22 is working for Medtronic or some other suitor whom wants to keep price in check prior to FDA approval so that when approved and it soars, it will do so from these levels and not from the $ 5 level. There is an incentive to keep cost of buyout in control. It could be another interested acquirer too.
As people said, oozhee22 is too well informed, he is patient and has lots of documentation so someone with interest is feeding this to him. Not even a long investor with a massive position goes through the paperwork he does.
A good motive would be to paid oozhee22 a salary to keep price in check. Instead of costing say $ 1 billion on a buyout, it costs say $ 400 million, so saving $ 600 million would be worth the $ 100,000 paid to oozhee22 to throw trash at investors and keep price in check.
What matters is how the FDA Panel voted and, the FDA always follows FDA Panel recommendation when then agree to approve. I do not have one (1) case where FDA Panel voted yes for approval and FDA then turned it down. The reverse is true where FDA Panel voted no and, FDA voted yes.
On matter of safety again what counts is FDA Panel votes, which I believe was 9 to 0 positive. So no matter what Jama said, or oozhee22 says, what matters is how FDA Panel voted.
On the matter of FDA who does vote itself on approval, they have already stated in their own briefing documents that reason for miss on efficacy was too high of a sham placebo result which was unexpected and unaccounted for in their protocol. In other words test conclusions were a bit flawed to the downside for efficacy due to high placebo results which FDA accounted for much lower.
In terms of market, it is clear that with VVUS and ARNA plunging, with OREX on hold with FDA plus with most people on the sidelines for bariatric surgery of stomach removal that there is no real alternative out there for obese people except to die.
Given simplicity of VBLOC procedure, minimal cost involved as people spend more on vacation and diamond rings than on this surgery, and that it is safe, I see no problem with ETRM becoming leaders in this field and taking a huge chunk of the market.
This is the greatest fear of pill companies and of bariatric surgeons, hence the likes of oozhee22 show up to cast doubt and stall competition as long as possible. When FDA approval comes and it will be YES, the days of oozhee22
You can expect millions of operations due to simplicity of VLBOC, taking most of the 200 million USA obese patients.
Found this video, it is so simple of a problem compared to stomach removal.