Hey moron...You had a group of surgeons looking at efficacy. Some said they were not qualified. I asked you last week to find any ADCOM device committee that had to look at a
device that was also a therapeutic. They were all surgeons and gastroenterologists. They were clueless regarding efficacy and you know that. The surgeons said it was safe. They said the risk/benefit was positive 6-2. The FDA in attendance was not hostile. 24 month data is overwhelming. This is the only chance obesity will be attacked. Take you pills and use them as suppositories. You are a complete moron.
August 7th edition of Newsweek..COVER...
" Mapping The Body's Wiring For Medical Breakthroughs."
The cover is actually an xray of our device and Enteromendics is mentioned in the article.
This is just beginning.
Today's Wall Street Journal features and article written by Dr. Kevin Tracey, a prominent neurosurgeon who was cited in the New York Times Magazine article in May. While it is opinion piece criticizing the FDA for its archaic
rules and glacial movement, it does highlight the success of his bioelectric treatment for rheumatoid arthritis and its very obvious success. If it works for rheumatoid arthritis, the path for obesity cures via the same route
seem very straight forward.
They have it pretty well set. The data released was much of what we know. 600 patients and no serious events.
Said the FDA is more focused on safety and benefit versus risk. Still before the end of the year to hear so that has not changed. He has all the centers teed up and they are in major metropolitan areas and all were used
for the trials. The part on how bad obesity was and the 70 co-morbidities was staggering. Talking to third party payers during this FDA wait time. No moss growing here. Listen to the replay. Feel that out of U.S. will be
partnered. He said we do not need a major sales force and growth will come immediately from the Centers of
Press release at 7 AM...But is you read between the lines the 3 year data is showing signs that the VBLOC
system can almost vanish Type II diabetes. If that is remotely close to the truth this will change the diabetes landscape. The hypertension data is must be even better. Harvard doc presenting.
There is a lot more to this company than you or the market appreciates. What else are they working on using their technology? Obesity is just one indication. If you read the New York Times article and saw the money Merck put up to get their feet wet in the bioelectronic space, you have to believe Knudson is not spending time looking for other indications. The FDA will address the device sooner than later and it will become the standard of care. The insurance industry will reimburse as they know the benefits are all downstream.
Do not be so quick to think sale of the company. Once VBLOC gets a head of steam we would be nuts to sell the company. This will be a process and I am loathe to sell our science as there is a lot more we can do.
We are still under Wall Street's radar, but as far as I am concerned the company is like an iceberg. Most of what constitutes Enteromedics is 90% unseen.
Sentiment: Strong Buy
What you do not seem to understand, and a fact made known by the panel is this ADCOM was a first in the device space. It wasn't a new knee, or pacemaker. It was a weight loss device where a group of surgeons who are tasked with implanting the thing ( which they agreed was safe) was asked to look at the clinical results against an implanted device that was not turned on. These people were clueless. They had no experience in the matter and stated so. The one fellow wanted 3-5 year data after he said it was safe to use!
By September there will be 24 month data on the implant group. Further, the FDA had trouble filling the committee because there was no one with experience looking at this type of trial. It was a first. Why don't you surprise us with your analytical skills and find a similar trial where a device was used against any placebo in any disease. I looked back 10 years and found nothing. This committee ruled it was safe and riskless. How well it served the purpose of weight loss was something they should not have decided. Time will tell and with the safety recommendation the FDA will allow its sale. This was a device committee, not a therapeutic group tasked to evaluate it against the same device that was not turned on. This is a case where the placebo effect surprised all. This also was a first event. So just give it time and stop playing devil's advocate or trying to tell us you know something we don't.
Sentiment: Strong Buy
They are capitalized leases you idiot...If they borrow short term they have paid it off with stock issuance.
Please get lost. Everything you cite is public record. Why don't you call some of the institutional investors and ask them your sophomoric questions.
You are an idiot..get lost
The device will not cost $10,000. It will move like knee replacements which started out high and then
competition got them We are the only device right now but after approval there will be lots of others. Now there are 9 companies that make artificial joints. Our patents will hold for 3-6 years...lots of litigation fees I
suspect...but we must make the device smaller and less onerous. The 30 BMI girls will want to wear the device under their bikini top!!!!!
500,000 patients? Not even close ADE. They will be lucky to do 50,000 in the first 18 months. Many
surgeons and gastroenterologists will watch and see. We will be 1/3 the cost of bariatric which will make
us very attractive to the insurance folks.
I know it is your opinion and I respect that, but please your math is lunacy. 50,000 units at $5000 a
pop is $250 Million making us wildly profitable in 2016. I see $4.00 a share net in 2016 against a PE
multiple of 20 ( Medtronics ) this a price of $80...assuming we are not bought out in 2015 which some
wholly expect. Dr. Kevin Tracey who was featured in the NY Times on May 23 has a neuroblocking
technology for rheumatoid arthritis. He has a few patents and he can do what we do eventually. You
can patent devices but not the vagus nerve. We should buy him right now but I suspect GSK or MRK
has made that call already.
Sentiment: Strong Buy
Pharma...Some of the patients actually discontinued their medications! That is quite amazing. While a small sample no ASEs and 83% had improvement or no change.
You make two flawed assumptions..One, and important is that we will get universal acceptance right away. That does not happen unless you are Gilead with a drug that cures a disease. Number two, they are talking to insurers and Medicare now to see where the
price point will be accepted. VBLOC does not save lives. It halts the progression of obesity in a very welcome manner but it is not a cure. It is part of a cure. Sure they do 300,000 bariatric surgeries a year but with Al Roker parading around the folks with $30,000 will take that short to skinny bet. And you are not telling us anything we do not know about obesity.
And the 300,000 who will switch? Where do you get that idea? They are not going to our device once they have a band or staples. We are going to get the new people who are afraid of getting gutted and don't have a terrible weight situation. The 400 pounder is not
coming into our centers. We will have enormous appeal to the 30-40 BMIs and should be doing a trial soon on the lower weight classes.
Insurance will pick up VBLOC. AS you smartly stated the future expenses of obesity are
staggering and the insurance folks know that. All the orthopaedic guys should start
worrying as most of their cases are not football injuries but FAT people who are wrecking
their knees and feet. And we do not have the resources and the distribution to do more than
50,000 in 18-24 months unless we get a pile of capital or a huge partner.
The company says $10,000. They will go where the price point gets reimbursed. I think
$5000 is it. And pal, they do 50,000 in 18 months ( trying to be conservative ) at
$5000, the price of our stock will be fine. Let's wait for the FDA and see where the chips
Sentiment: Strong Buy
You learning that now..The old Lou Gerstner two step...This company is a joke. Negative shareholder equity!!!
The stock would be at $20 if they didn't keep buying but the real fools are the bond buyers. And S&P still has an investment grade rating!
What is going on is folks like you keep asking what is going on! This is a massive quiet period as the company is waiting the FDA decision. Don't expect anything out of the company until then. They can't have conferences and press releases. That is not how it works. They have to be sensitive to what they laid out before us..ADCOM then within 90 days the FDA decision. My guess is they are talking to the FDA all the time. Trying to make the device smaller and get better battery life. But don't ask questions that you know the answer to. They can't say much if anything. Put the stock in your drawer and ignore the doom-sayers that appear every day.
On another note I researched FDA device data back 10 years and have not found one instance where a device was in a clinical trial where it was also treated like a therapeutic. Maybe there never was one. I asked that idiot Oooze whatever to find one and he can't. This was a first for the FDA and you could see from the ADCOM discussion that was the case.
You have to be patient with companies like this that have a first of a kind device that could help a lot of people.
The morons on this board who own ARNA, VVUS and OREX will not let up until the FDA decision and all they are doing is tossing stock between them. Sure it would be nice if Knudson did a Cowen road show to meet new institutions but that is not going to happen. Nor will we see much research. It is a very quiet period and you should put the dopes on ignore and take a vacation.
Sentiment: Strong Buy
How much capital did Amgen spend before its first product? You can look at any 10Q or 10K from any
developmental company and read the same things. You take us for idiots? ETRM does not have 200 Million shares outstanding like a lot of companies.Take your pals at ARNA. They have 216 Million shares outstanding an a 1.2 Billion loss carry forward. I could go into 200 balance sheets and get the same data you get from ETRM.
Your analysis is bogus. You have no idea what you are talking about. The way a company raises capital and how it develops its products is simple finance which you do not understand. How would you have them operate away from selling stock? And a shelf registration? You read 10Q boilerplate statements and assume none of us know what is occurring.
One trick pony?? Sure, but it is a trick that is going to make the company worth a great deal.
Before you opine first get an understanding of how small developmental device companies and biotechs
operate. I suggest you wait for the the FDA decision then tell us now smart you were to sell. Your 10Q
diatribe is useless.
P- After I heard Knudson today he filled in a few blanks and he really emphasized there is nothing out there to treat obesity. The profile of how cholesterol, blood pressure et al reacted to the device was
a stunner. With the NewsWeek article and other similar writings once we the approval things will start to happen quickly. How he had the centers described and how they are in major metropolitan areas was also something I didn't figure. Then again, I wish they spoke about a miniaturization of the device and what other diseases they were contemplating attacking.
There is nothing out there to help the clinically obese. Period. This works and his confidence is
high. I wish he was a better speaker, but in the breakout sessions some folks paid attention and
may have bought a few shares. We have a lot of technical damage, but that repairs itself.
Sentiment: Strong Buy
There was a May 23rd article in the New York Times Sunday magazine entitled " Can the Nervous System Be
Hacked." It goes into depth of the new science of bioelectronics. It is by far the best article I have read regarding
the potential and where I think ETRM fits and how far ahead we may be.
I love your enthusiasm but your estimates are wildly off the mark. There has never been a mention of the number of patients waiting. If Mayo had 700 waiting they would buy ETRM. We are never going to hire 100 salespeople as this is a device and the big hospital players like Thermo and McKesson and Medtronics have that infrastructure in place. And GSK preparing a bid? You work there? GSK is the only big pharma
mentioned with a stake in electroceuticals. Merck just paid $10 Million to start a process. While I am pretty confident of the FDA approval, it will take a year at least to get the hospitals up to speed. The process of acceptance and selling is not as simple as you portray. They will license this device in my opinion and expand the technology at the company to get into a great many other areas of need. By Q4 2015 I think we will be profitable. ETRM is not going to spend a lot on bodies. They will focus on manufacturing and improving the device initially and then proceed to other areas. They may get an offer but I think the big reward is our patent estate and the lead we have in the technology.