I have never seen such sick and useless posts as I have in the last few days. Accusing the company of mismanagement, saying the longer the process goes the worst it is. One long term holder threatening to sell his position. This is total garbage. There has been no change. Accusing Jody of lying. Accusing the company of non-disclosure. The height of stupidity is calling it a fraud. That is slander and when the smoke clears I would say he could need a lawyer.
We are caught in the grips of a bureaucracy that has its rules. This is a device and the data and information should make it seem simple, but the FDA seems intent on making itself important. If this device was going to get turned down it would have happened. They have approval in the EU and Australia and that is not fraud. That is real. I come away thinking we are close to a approval but the time and the wear and tear on a lot of people is making it easier for the short sellers and morons to affect opinion.
I am buying more and all I can say is thanks for the cheap stock.
Please ignore these idiots and have faith the company knows what they are doing, because our device and moreover our science will succeed.
Sentiment: Strong Buy
I will post these as I get them if that is OK with you guys....
This one is very good!
Do you understand disclosure????? If they have nothing material they should say nothing. You are losing money like I am but I believe there are a lot of moving parts now and we have to wait until they disclose them. They know what they can and can;t say and they do not wnat to be hypsters and they have lawyers advising them. I believe the stock fell because they took down 10 million shares of the ATM and Cowen is a thinly capitalized firm that does not cover the company via an analyst. Get a lawyer Why? What did they do wrong? Their stock fell? If that was the case 50% of the NASDAQ would be sued. Relax and have a cocktail.
What do you want them to say? They said they are concentrating on theri 13 centers and want to have 20-25 centers by the end of the year. While getting all the press and TV spots they have to prove the device is viable by selling it. They hired an experienced marketing guy. They said in theri last calls they were having discussions with potnetial partners. They said they are working on the CPT Code issues. What else do you need?
...that the ground is shifting under management. Obvious to me and now ETRM that the IR/PR folks did a great job and the response has been enormous. I feel they may even cancel the BIOCEO visit as demand for the device may be greater than their internal projections. I hope not but if they do I would not be surprised. The sophomoric complaints that the company is not telling investors everything is groundless. Having a call with patients and doctors has no financial bearing on the company. I do not think they are counting the numbers who call. I do believe the wating line is forming and callers on the Webinair will most likely be referred to whatever active sights are open. The doctors on the call will do everything to learn the procedure and get their local hospital geared up. This could be huge for the docs and the hospitals. However, I believe ETRM is not prepared for this at all and it will have to make adjustments. We do not have the staff to open a lot fo sites. They want 25 by the end of the year, That is doable but they need help......MORE
I like this. Medtronics oars have been in the water dealing with COV and they received European approval yesterday. I have to believe come hell or high water Knudson has a deal with Medtronics for international selling if he wants it. ETRM has done the heavy lifting in Europe and this is an easy one. Upon approval the next announcement will be a non-US deal to sell VBLOC. This could be a billion dollar product without much effort in my humble opinion.
Sentiment: Strong Buy
I do not care when the FDA reports to the company and I enjoy the blather about the price change afterward. In drugs you can draw a reasonable assurance as to sales, while devices are a completely different animal. How many small device companies are there out there? This NVRO new issue pain company is just that. A new issue with all the specs playing. ETRM will get approved and there will be a 100-200% price increase in the stock. You will shake out the specs and day traders and then you will address the shorts, who I think are all the warrant holders who will cash their warrants and cover their shorts. They lose out forever. The next 3- 6 months will tell the tale in the U.S. as to demand for the device. I still believe they will do 50,000 procedures in the first 18 months. But the real interesting events will source around the international deal they sign. I see a minimum of $100MM up front and a double digit royalty. Then I think we will get a look at their science which will have a capital base on which to proceed. I have wondered why they have not done a deal away from obesity but I suppose the FDA has been all consuming. The FDA has taken it time with ETRM for reasons that will clear. I think they would like to move the BMI minimum to 30 and I think they may have interest in the next generation of device will will be smaller and less of an implant problem. This is still the singe best investment I have seen and while it will take 3-6 months eventually major investors will agree.
What we know and do not know. VBLOC has been approved. The FDA announced it was based on the ADCOM but the 18 month data was convincing. We have approval in the EU and Australia. Obesity has been declared a disability in the UK. We have a diabetes EU mark. The FDA approval will make life easier in Asia and we have not even broached the subject of an Asian partner. ETRM has 13 centers in the U.S. the major being the three Mayo Clinics. The have said they will not need to raise capital. There have been trial balloons by us and the media about the cost of the procedure. Until the company announces it is a point of debate only. We know of their patent estate and the value of their platform. We have an idea that a foreign license deal is a foregone conclusion and the FDA approval raised the ante for whomever we are speaking with. The news has been portraying the device as a first of a kind which it is.
I wholly expect the next 60 days will be very informative. I expect a very financially profitable deal on the worldwide rights. They would be foolish to even contemplate going it alone. They will receive an upfront and what I think will be a fairly robust royalty. Whoever they make that deal with I believe will eventually buy them but that is a later discussion. FDA approval may bring in other players especially in Japan and China where obesity is really a problem.
I stand by my estimate of 6 months ago that in the next 18 months 50,000 procedures will be done worldwide and the VBLOC will continue to receive acceptance. Then I expect the company will do a collaborative deal with a major drug company with a totally new indication. Our platform will start to take off.
That is it folks. I think this management will perform even though a lot of displeasure has been voiced about their performance in the last 6 months. I do not think for a moment they were asleep but were advancing the approval and reimbursement avenues.
Sentiment: Strong Buy
I knew quite a few pals who worked in the knee, hip replacement business. Once the docs were trained it was an annuity for the company. That to me is the mountain to climb.ETRM must tether themselves to someone who can establish centers within a hospital system. I am guessing at this. They had to see the demand and it had to be multi-geographical. It could have been overwhelming I hope. I also hope they raised some capital. A lot of people who post here are very naive and think this is like putting Coke on a shelf in the market. It is far from that.
While it is a simple operation it is going to be a complicated set up to take it as forward as we all hope. I am convinced the market has no idea how big this device could be. I feel it is already miniaturized and since approval they have had to be working with existing implants to change some of the degree of charge differential. This is now going to get exciting. The trial used the same settings. Different settings may bring more weight loss.
Pharma or others could comment on that. The operatins fellow they hired will now take a bigger position and responsibility getting this device to market. This demand will also accellerate their international deal as they will have to get a partner to handle what will be a market twoce the U.S. market.
Bottom line...Exciting times.
Sentiment: Strong Buy
I hate to post after my own posts but I have to believe approval of our device is imminent and from conversations with the company and listening to the conferences I can't imagine why they would hire an operations guy after 5 months of dialog with the FDA. Also people are ignoring the real story in my opinion of the science and technology we possess. I know of four drug companies involved in the space, but they are mostly ones dealing with the head and pain. The real commentary from the company which I have never heard is what other targets are they planning to go after post FDA. I think it will surprise even us. Good weekend all.
The Twin Cities news on January 31 quoted Knudson when asked about reimbursement, "That is an 18-24 month process and we are in the middle of it." Imagine if we heard before the end of the year that we acquired a CPT 1 code. He also stated, which I thought was surprising regarding the pricing that it was part of the coverage discussions with insurers. Question. Do you guys think if they price it at a reasonable level the private insurers would be quick to cover it? We know what insulin and the diet pills cost. And secondly, which I also think is vital, do you think they are working on a smaller device that is more powerful?
Sentiment: Strong Buy
We were correct to assume they used the ATM. The dilution was a lot smaller than I had expected, and in a way that seems positive as they could have taken down all the $25 Million. Obvious they expected a big bump after approval. The use of the funds in Q4 were to be expected and we will find out what other ongoing activities they were doing. Nice to see if we have other indications. Too many people here expect this company to be an immediate ongoing operating entity. It does not work that way. They just received approval on January 14 and today is February 18th. They will lay out their game plan and it seems they have no concern about funding, although I wish they took down more. Obvious to Pharma's comment they have seen demand and building inventory is a clue. They will begin with the existing centers and as Knudson mentioned they want 20-25 operating centers at the end of the year. My guess is a lot of the capital was used in that direction. The ATM taken was small which seems predicated on the expectation of immediate sales and use in the existing centers. Mayo has to be doing business now but at what price? Regarding prices of implants, I never saw a quoted price on my knee implant anywhere, but this device is quite different and I hope the company addresses that today. I think a reasonable price will spur self pay demand. Oh and they should get Fox's Dr. Alvarez in the OR quick and give he a "Roker Freebie " so the world can see the results.
I am very comfortable here knowing they focus on capital and the small take down is very telling to me. If Lea and Hancock needed more they would have taken down more.
New company, new product, Fat America!
Sentiment: Strong Buy
Mayo did the most of the clinicals..They are geared and ready to go in their 3 major centers. The company has to be talking to Medtronics/ Covidien or others to take over international scale up for an upfront and large license fee. They will get the funds to open new trials in new indications. They have a huge patent estate that will make us very attractive to big pharma.
You sell your stock here and you are nuts. It will take two to three months for big investors to get their arms around this. The IR/PR firm is geared.
Sentiment: Strong Buy
All this volume is the specs getting out. The company now has a device that has been approved basically worldwide and they will act to get an international partner. The FDA approval just raised the ante a great deal. They WILL NOT finance. They have inventory which is being shipped as I type and the Mayo centers are ready to roll. We have a huge cadre of obesity organizations that know about us and can read results. We may have another day or two or the idiots taking their lumps but please long term holders do not #$%$ and moan about the activity. This is obesity where nothing has yet to work. ETRM is going to change that.
To the dopes who sold me shares at $1.24 I thank you.
I hope to speak to the company and find out just what else is in the pipeline. They know more about the GI system than any other neuro-blocker entity. I expect within 3-6 months we will have a collaboration with a major drug company on one or more indications. We have our device and it will find a lot of users and we will license our technology instead of doing it ourselves. Wall Street from the SA boys to the Zack fools are so far behind the curve on the company that it is laughable. I doubt Cannacord et al has the power to take us to the next level. I will be interested to see who picks up coverage but it will most likely be some of the folks who follow Medtronics.
This is the best investment I have which is trading at the price of an eternal option.
Sentiment: Strong Buy
I have you on ignore but read this comment out of curiosity. How could they give you a target? It is a new device with only 600 known implants. It took them 10 years to get here and you want them to give you instantaneous projections? They are having webinairs for surgeons and patients. They just got their salesforce trained and on the road. This is not Solvaldi. But it has a bigger market than Solvaldi. Did you not hear Knudson say on 1% of bariatric eligible folks with BMIs 35 to 45 get the surgery? He said there are 28 million of those folks. This is not a low risk stock and they are in the process of finding their market. Look, John Arena and Viivus and Orex could not find a market because people knwo pills do not work. Surgeons do not do a lot of lap bands as hey have been pretty much a disaster. Give this company a break and some time. Call them They are very open.
The only thing I am sure of is death and taxes. I am also sure 23 million fat folks are eventually going to get around to VBLOC via there docs.
Sold $17 Billion of bond yesterday to buy Covidien, It was a massive deal and they stole the money at very low rats of interest. Now they are an international player and will be very aggressive in acquiring new technologies in every aspect of health care. ETRM is in the sweet spot and with their marketing power they could make VBLOC explode worldwide. Medtroincs is going to need new revenue sources as the there has to be some overlaps in products and the economies of scale created by this merger are usually not long lived. Something to be followed.
If you read the transcript you would have seen where the panel with one exception were satisfied with the data.
The company has constantly been giving data to the FDA since the ADCOM. About three years in some cases.
Do your homework before you make inane comments.
Today's Wall Street Journal on page 1 of Section B " FDA Clears 'Pacemaker' For the Stomach"
It was an interesting article with most comments positive but seemingly enough caveats from folks who want to see the device work. We just have to look back at the pills from ARNA, VVUS, and OREX to see the skeptical bent of investors toward diet remedies. This is a whole new technology and not really the Pacemaker described by the article. While Pacemakers and VBLOC have the same surgical methodology, the technology is different. But time will address the obvious difference of VBLOC to pills and the bariatric gutting.
I am surprised that they are still talking about pricing the device near band surgery. I think the company would be foolish to put a high price on the device. This is going to be the first of many applications for our platform and I will be interested to see what other indications they are planning. But first things first. Mayo has to be teed up to start within 30 days at the most and the partnering in Europe should be done within 90 days.
I also refer you to the transcript of the ADCOM June 17th meeting and the number of societies and groups who spoke in favor of the device. There were some that had 5000-7500 members involved in the weight loss business. It is like we will have a pile of advertisers working the clinics for us.
We are different than pills and bariatric surgery but alas have to start under the cloud of diet remedies that have not proven effective. The market will eventually understand. It is going to be an exciting year, so fasten your seat belts and helmets on! I also refer anyone interested to the May 23 article in the New York Times Magazine entitled " Can the Human Body Be Hacked." It perfectly describes the technology at ETRM and I know we are by far the leader in the space of neuro-ceuticals.
Sentiment: Strong Buy