Give me the device name. This is for sleep apnea but I know very little about the device. It can sell much does it?? I am not a doc so HTN is just as alien to me.
Some background is what I need.
I learn something new everyday. We charge from the outside. Pacemakers I know and this device seems just like a pacemaker. Could you explain the therapeutic action of the device as I have never heard of it. Well I will Google it first.
There are a lot of shorts, mainly by warrant holders who toss the same short to each other each day. It costs 7% to borrow the stock. That should educate you.
And that device works with the same mechanism as VBLOC? I do not think so. There have been a lot of neuro-stimulators but correct me if I am wrong they all are external.
Thanks for the response. I am sure the FDA knows of its short comings but it is a massive bureaucracy and one of our nation's problems. The government is too big.
But I think yours comments about the EU are correct and they are not as large.
Dopes like you want this success to be instantaneous. This company has not been around a long time. What the hell do you expect?
I do not think it means much to the FDA in terms of our application. They know about it, but I doubt it will make much difference in their decision making process. Maybe someone on the MB with and FDA background could answer that better than me.
Front page on FDA and medical devices. Interesting they looked at 3,000 devices in 2013. I would venture to guess that the majority were "me too " items but I am getting a clearer picture of our delay and what it may mean. VBLOC is a first of its kind device which has received high safety and benefit responses from the ADCOM. Be that as it may, VBLOC is the first electroceutical and from that article I could see why the FDA was the target of a WSJ story a year or so ago because the device in question ( morcellators ) were causing widespread cancer in some patients. If you see the picture of the device it look like it came form the 15th Century. But our device is a first in kind and I imagine the FDA is constantly asking for updated data on the patients that still have the device implanted. Our side effect profile was very small and ASEs were almost nothing. There was no drug interaction. But in the eyes of the FDA this is a new genre of devices and while it seems simple bureaucrats seem to make mountains out of molehills. The length of time to approval is not a cause for concern in my opinion. I think they are crossing t's and dotting i's.
Sentiment: Strong Buy
You know Gartman..He is long oil in shekel terms. He is a legend in his own mind whose circulation has fallen further than CNBC's ratings. He is an idiot. When oil goes up he will say he called it.
I have seen unreal expectations fulfilled so I hesitate to throw stones, however after approval it should trade $3-5 and the traders will unload..Trade back ro $3.50 and wait for the company's conference call. I believe they have a international license deal as they have not spent a dime there. Imagine having an approved device in Europe for obesity that showed 24% EWL and it just sits there? We get a CE mark for diabetes and it still sits there? If the FDA denies then they license overseas, But this approval will get ink within 60 days and the conference call will clear a lot of questions. The delay is unnerving a lot of investors and that is no fun. But the stock market for small stocks is awful and only the big liquid stuff trades. There is a lot of guesses here by the bulls and bears which is good. The data are real and the facts are hard to dispute. There are a lot of fat people out there and there are no easy solutions.
People on this board are not dreamers. They are investors. We have information and we invest. Rule One- Medical devices are not sexy, drugs are sexy. Obesity is a terrible disease but all the overweight are looking for quick fixes and a pill.
Not happening. Rule Two- We are sort of investing in the dark when it comes to disclosure. This company says very little and that is FDA induced. Rule Three- The dreamers here understand the case for post approval announcements. The negative posters believe management to be cashing checks and waiting around.
We dreamers do not think that is the case. Sometime soon we will get a decision.
The fellow that says the longer it delays the higher the chance of rejection has no idea what the facts are but it just continues to elicit questions which will be answered soon enough. The only "dose of reality " is what? Approval. Denial?
For a long you seem very negative and you bring a sense of non-sincerity. You must be the seller of the $2.00 calls hoping they expire worthless.
I have stopped replying to those folks and put all on ignore. If ETRM was $25 a share and standing in front of the FDA then shorting an misinformation would be usual, But as you say we are at $1.37. That is the cost of most long term options. The ADCOM data and commentary is compelling. Safe, Beneficial. I am not sure of their motives other than they work for ARNA or OREX? They may be the warrant holders who sold and can't buy back real shares. The cost to borrow the shares is still high. We will know soon enough and go from there.
Obesity is growing and there are no reasonable solutions. The pills are all failing and bariatric has so many reversals it is hurting that growth. VBLOC may be a great product as the research goes on for a better solution. Local paper here had an article on the Roche guys synthesizing three stomach peptides and making fat mice slim. I applaud that. But as all can see people are eating right through the ARNA and OREX pills and the docs are not writing scrips. I wish the company could somehow release data on the number of patients still on VBLOC since the trials began and where they stand. I think it may be embargoed by the FDA and the application but I am not sure and the company will not answer my question. The people in the trial like the fellow who testified obviously have a confidentiality agreement. But I think soon we will all know the outcome and I suggest we all go have a nice Holiday.
Sentiment: Strong Buy
The science irrelevant? You are dumber than you sound. And what is there to rebut. Your arguments are specious I know the results of the clinical trial and in conversations with the company I find there is another generation of device and possibly a trial ongoing in lower BMIs. The anticipated labeling is publically available? #$%$ does that mean? I have not seen that. Can you point us in the right direction.
Please go argue with someone else. I am putting your #$%$ on ignore.
No jerk off I read nothing and according to you know less than nothing. So you are right about everything and I feel like such a fool trying to match wits with you. You must be a practicing surgeon and Harvard Law graduate with extensive experience in patent law and the FDA. What Harvard class? Maybe we met?
Off label use would really connote another indication. My Aleve bottle says not for children but you don't think kids use it?? The off label use for people with a BMI off less than 35 for a device seems so innocuous to me that it will not matter. They can go back with an amended application once the PMA is approved. But in all this bumpass debate we are overlooking one thing. The guys that run this company are not getting credit for anything and we are all WAGs when it come to what we expect. Most here think it gets bought out. I don't and I would fight that as I have been constant in my commentary about the science. VBLOC is wonderful but it is what is under the ice berg that gets me thinking. If any of you have not researched their patent estate you might think it interesting. A lot is scientific but it is a pretty powerful estate and the application are the same way.
We are all waiting for the same thing. Once we get the decision we can debate, but I feel the company has a lot of the spaces filled in.
Hey 50,000 units in the first 18 months. Go back and reread genius. We know you are here to help us understand what we do not know. What do you know about the science and the methodology of setting the device for different weights? See you in 18 months.
Did you read the transcript? We had 20% of the patients lose 50 excess body weight. They were all
set at the same impulse. What are you trying to do here. You act like a short who wants to put doubt in people's minds. You obviously do not know how the trial was set up and you can't seem to see the forest through the trees. Telling us we do not know know what we are talking about? You are a bigger fool than I thought.