All you have to look at is the success of the ARNA and VVUS drugs. And Contrave will be just as bad. Minimal weight loss and a potential side effect nightmare. We just have to be patient. The obesity space will start to get some attention if the dopes on the financial shows can forget about Apple.
Sentiment: Strong Buy
22,000 shares traded after hours in small lots..Who cares...day shorts cover a bit.
All it does is elicit comments like yours. Paint job.
China is a big place and we have Chinese partners. The powers spread the wealth usually and the SCOK news while interesting should be addressed by Rigdon. I think he is run his term for lame excuses and he
needs a win very soon. The cash flow obviously is a great help, but the market needs something
substantive. His entire net worth is SYMX and I have to believe he is maxing out the effort. It will be an interesting call none the less.
I do have to say our IR/PR is awful. You would think a message would have been sent to the
Wall Street community by their outside IR//PR folks.
KERX drug is toxic and has a warning label which if you read you would never use the drug.
DSCO drug is so small and not very good.
ETRM addresses the biggest disease category in the world. We are as pointed out unknown
and under every radar. Look at Intercept and they are in Phase II. Look at PUMA. This is a device
that is also being judged as a therapeutic. That has never been done in a field of science that is only now being recognized.
If the get approved they have two choices. They can license the non-USA rights or they can finance.
But this company is a device seller and not a surgical company using its own device. If they finance
to expand manufacturing and sales I have no problem.
The demographic question was brought up by one of the 13 people who were allowed to
comment at the ADCOM meeting, not by a panel participant. And really, give us a break.
I played football and baseball in college and did not notice any difference in the African American and Asian guys I played with. We are all humans and have the same basic
make-up. If you study the human body you will find all parts in every race are the same.
While obesity in the African American community is great than whites, and Asians are
on the whole thinner than both, it should make no difference.
The reduction of comorbidities was a comment not included in the FDA request and was mentioned as an aside. The company was not asked too track them but they did and reported out the data at the meeting. The FDA required a 10% difference to the sham and for no other reason than they had no internal quidelines. Read the Lerner letter.
The company data on comorbidities was just after the 12 month study and further data
may have been released but I am not sure or have not read it. As I say it was presented by
the company for information only and Dr. Kral's comments were his own. I did not read where anyone else on the ADCOM agreed or disagreed with him.
My understanding is some folks on the trial saw lower cholesterol which is obvious if you
lose weight, and lower blood pressure which also is a side effect of weight loss. I went from
250 to 180 and my blood pressure went from 138/93 to 112/58. That was in 2001. But
folks dropping off insulin. That to me was a shocker.
You must be a fat white woman. Sorry. They reply was to a question from an idiot.
Lipitor is generic by the way. You will not see 121 until 2018 at the earliest. In the mean time we await the long
promised deal and the money clock is ticking.
The length of the study was dictated by the FDA. The concern was voiced by one panel member who thought it should be a 3 to 5 year study but the panel chairman basically ignored him. And just white women? Are you
really asking that question? The study parameters said NOTHING about RACE or SEX or AGE. It was totally based on the BMI. The FDA sets the ground rules and your question is ridiculous at best.
There was one major concern. Patients with the implanted device could never get an MRI.
The FDA can make any rules they want but restricting it to fat while women? That comment does not even
reserve an answer. Go back to your comic books!
Old news and difficult technology. Was reported in Fierce Biotech last week. No chance vagus nerve
interruption would stop a heart attack.
Only an idiot would try to manipulate a $1.40 in front of an FDA decision.
He is an ego maniac. He wrote the SA piece and still does not know he is wrong.
I wish he would take our advice and desist until the decision. They is we get
turned down he can gloat.
Bamm..The most telling data which a pal sent me from that FDA was the following:
" The panel did agree that the 18 month data did support the effectiveness of the device since there appeared to be sustained weight loss."
The panel was only asked to VOTE on 12 month data, but from the FDA paper you see it must have been a
unanimous conclusion that at 18 months the device was effective. If it was an 18 month trial we would not
be here debating that idiot. And having no pre-specified endpoints for any physiologic parameters like
blood pressure or cholesterol they did pay attention.
They paid attention and we can see just how unusually hard the parameters set by the FDA were.
ETMR has working long to get to this stage and rooting against this device is like rooting for obesity.
Medicine and discovery is done in small steps. I would love to see the first 200 bariatric patients and
where they are today. The patients who tried Stryer's first knee replacement had it done four times more until it fit. I wear contact lenses. For 50 years. I remember the first one I plopped in..
Technology advances. Look at robotic surgery. ETRM has a great device and it is going to be
miniaturized and it is going to be improved and after approval the FDA will ask ETRM to do a trial
with people having a BMI of 30. They will make it so small a woman in a bikini can wear it.
I imagine every model and actress will have one put it. It is the beginning of the end of a terrible
disease and right now the safest product on the drawing board, including pills and bariatric.
The bariatric surgeons who wrote the JAMA counter piece are idiots. They are the guys who are
going to do all the procedures. But you threaten narrow minded people what do you expect. That
fellow OOOZE has specious arguments and no logic. I still can't understand his continuous berating
of ETRM except he penned that SA piece and if he fails he has to find another career. To me he is
basically circling the drain right now.
I do hoe the FDA acts faster than their rules. It is a device not a pill and has approvals already.
And guys lets not take shots at management. Their personal stakes are a lot bigger than most of
Sentiment: Strong Buy
ADE I know the people at Medtronics very well. They are very honorable people.
That idiot has no association with them.
The liability for Medtronics would be staggering if that is true. Look what they are paying for
Covidien. Money has never been their problem. That idiot does not work for them. Relax
Debating any point with that fellow is like talking to a four year old. All your points are in print on the FDA web site. Put him on IGNORE and just let him talk to himself.
He is proof positive the Indian had congress with buffalo.
I had to open his comments after your comment. Bariatric is not paid for, nor are face lifts.
If that moron went to the FDA website and read the post ADCOM comments he would
stop being such an idiot. But after I read his comments I agree he is becoming a quite sick
fellow who most likely needs years of therapy. Feckless..he must have used Wikipedia to get
that word. What do you think? Abused child? Mother issues??
They have to stop all this intent baloney and get something solid. They have more associations with
a multitude of companies that are not delivering new projects. They and GE have been talking to Pakistan
so long they may become Taliban! Rigdon has to stop the promises and deliver something. You can't keep
saying " the premier global gassification technology company " without getting something built.
China has said they want to clean the air and still use coal. How hard is it to get a deal done??
I have a big position and know where 20 million shares are....They do not have the shares to sell out.
They could license and that is fine. Giving up the patents and the know how is unforgivable. I am not
an activist but I would get a holders list and start dialing. I also know enough private equity guys who
after approval would be interested.
A therapeutic device is quite an innovation. The science can only get better.
Sentiment: Strong Buy
So much for the pills..$3.90 today for ARNA. All time low,,VVUS $4.01...another low...
The remedies for obesity are going to get narrower and the FDA knows the pills will not work.
The VBLOC will get a lions share of the bariatric business as time goes on.
I still think this is the best stock I own and it is going to be a huge winner. There will be more and more
articles about electroceuticals as time goes on and every major drug company is going to want to play.
They could pay #1 Billion for ETRM now and pay that off in three years.
Sentiment: Strong Buy