I got your number alright, you have not fooled me for a second. I have not sold one (1) share since you arrived. I must admit your constant bashing did make me conduct a more detailed due diligence which was reading 10-Q in minute detail, which I rarely do.
I feel more comfortable now than I ever felt before since I have done my homework.
The points you bring up have no validity at this point since FDA met ETRM before filing PMA and they were shown efficacy and safety results. ETRM wanted to know from them, should we file or not?
FDA encouraged ETRM to file an application agreeing to put the matter in the hands of a panel of doctors who would more easily approve the device, giving them an excuse to be more lenient on ETRM since obesity is truly a big problem in USA and very costly to treat.
The new FDA position is to approve devices or pills which have strong safety record and good benefits without necessarily hitting specific efficacy targets, which are artificial anyway.
What you repeat over and over again is HISTORY and yes it explains why price is at $ 1.28 however, stock market looks to the FUTURE and not PAST, so with FDA panel approving VBLOC in USA market which has MAJOR OBESITY problem costing bankrupt government $ 147 BILLION per year, you can be assured VBLOC will be covered by insurances and pushed by governments compared to status quo of doing nothing.
I posted this response to you however it is for the benefit of others too. I know you are a paid basher from the words you use, which investors do not. You are guilty as charged.
It depends who the investors are at this presentation. Is it individuals like doctors, is it firms who invest in biotechs or, is it to speak to competitors in the industry who look for opportunities to buy out.
We will know shortly,
I agree that a BUYOUT may be exit strategy for Knudson to cash in and allow some big MAJOR PHARMA to carry VBLOC to market.
There is a market for this device however stronger hands means more likely chance to succeed in material way.
Those poor people in the philippines are truly in trouble, children suffering from typhoon hit.
I would like to tell everyone, including PENNY, please contribute as you can. It is moments as these when you shine in Gods eyes in helping others.
We continue to evaluate the Maestro System in human clinical trials in the United States, Australia, Mexico, Norway and Switzerland. To date, we have not observed any mortality related to our device or any unanticipated adverse device effects in these clinical trials. We have also not observed any long-term problematic clinical side effects in any patients, including in those patients who have been using the Maestro System for more than one year.
In October 2010, we received an unconditional Investigational Device Exemption (IDE) Supplement approval from the U.S. Food and Drug Administration (FDA) to conduct a randomized, double-blind, sham-controlled, multicenter pivotal clinical trial, called the ReCharge trial, testing the effectiveness and safety of VBLOC therapy utilizing our second generation Maestro Rechargeable (RC) System. Enrollment and implantation in the ReCharge trial was completed in December 2011 in 239 randomized patients (233 implanted) at 10 centers. All patients in the trial received an implanted device and were randomized in a 2:1 allocation to treatment or control groups. The control group received a non-functional device during the trial period. All patients were expected to participate in a weight management counseling program. The primary endpoints of efficacy and safety were evaluated at 12 months. As announced on February 7, 2013, the ReCharge trial met its primary safety endpoint, though it did not meet its predefined co-primary efficacy endpoints. The trial did, however, demonstrate a clinically meaningful and statistically significant excess weight loss (EWL) of 24.4% for VBLOC therapy-treated patients, with 52.5% of those patients achieving at least 20% EWL. As a result of the positive safety and efficacy profile of VBLOC therapy, we used the data from the ReCharge trial to support a premarket approval (PMA) application for the Maestro Rechargeable System, which we announced was submitted to the FDA in June 2013 and was accepted for review and filing in July 2013. If the FDA grants us approval, we anticipate we will be able to commercialize the Maestro Rechargeable System in the United States in 2014.
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If we obtain FDA approval of our Maestro Rechargeable System we intend to market our products in the United States through a direct sales force supported by field technical and marketing managers who provide training, technical and other support services to our customers. Outside the United States, we intend to use direct, dealer and distributor sales models as the targeted geography best dictates. To date, we have relied on third-party manufacturers and suppliers for the production of our Maestro System. We currently anticipate that we will continue to rely on third-party manufacturers and suppliers for the production of the Maestro System.
Your posts show that you have alot of hurt and vengenance for ETRM. Were you the one who bought at $ 30 per share? Were you employed by ETRM and then fired?
You obviously have a chip on your shoulders for whatever reason against ETRM succeeding. Is this JEALOUSY I am feeling from you?
You waste your days, nights and time researching ETRM and posting only negative news. This is the characteristics of a pyschotic person who is not well mentally and only sees the glass as half emplty. You really need medical help to move on in your life.
Your jealous rage, hate, vengence against ETRM is the equivalent of a bitter spouse who got the short end of the stick. Did ETRM not pay you a proper package before firing you?
Your postings are boring and show a vindicative, malicous , bitter person who is out to get somebody for whatever reason you have.
Your credibiilty was shot the moment you showed your true colours.
No one believes you, no one trusts you, no one is going to listen to you and, no one is going to sell cause of you.
Move on to something better in life, maybe go to Church, attend a mass, repent your sins, forgive those whom you are bitter against and, do something constructive.
If a stock is trash then you don't need to be bashing since stock will deflate by itself. However when you have a poster like penny_dreaddful trying everyday with the same boring arguments to get people to sell, you have to ask yourself, what is he or she afraid of?
The more he or she posts, the more insecurity he shows the market. What can render him or her so insecure requiring constant posting of same doubtful stories?
Only logic is he or she is fearful stock will rally up strongly on material changes which are about to occur and hence will do all that is possible to halt rise. He works for either a competitor like ARNA who is worried about losing business to a device maker or for a hedge fund which is buying before FDA approves and wants cheapest price.
His line of "I am looking out for others" is total B.S. I did not hire him as a consultant, did you? So if he is not paid by us, he does not represent our interests.
Investing in market is always most beneficial when one takes contrarian position to what bashers want.
LOAD UP and collect on your triple within a few months.
There is absolutely no volume at this level at all. When volume dies out like this it is usually a sign that there are no sellers. Buyers come and go, but sellers are usually always there. So if sellers refrain from selling, once buyers come in, we SOAR.
I am looking forward to pending catalysts and see a rally developing shortly.
Shall we start an earnings rally to the 15th of November?
What is important is what is said about future and, not what is reported now. Bullish outlook will send up stock to new highs.
Better cover, you will not get another chance at these low levels.
Next week is Canaccord conference, week after is probably confirmation that response has been made to FDA and release of 18th month data, and week after that is probably confirmation of date for FDA Panel of doctors.
As I said, gap up to $ 1.70 and new highs shortly.
I guess bobhstimo is the new PENNY.
Ok so lets do it your way.
Remove mental power from both, remove diet and exercise from both.
VBLOC resulted in 8.5% loss of weight in one year compared to 0% for placebo.
For a person weighing 400 pounds, that means about 34 pounds off in one year which is very good compared to 0 for placebo.
If we repeat for 2nd year there will be similar approximately 30 pound loss of weight compared to 0 for placebo.
I guess this is why FDA wants to see 18 month data.
Does anyone disagree that placebo results are irrelevant since the WORLD knows obese people do not lose weight doing nothing.
There is not one person in the world who will believe that if you take an obese person, plunk his butt in a chair and give him a fake device, that he will lose weight. If mental power was possible there would be no obese problem. The placebo test should never have been done and it is poor comparatively to treatment arm.
The treatment arm showed a 24.5% weight loss improvement from beginning to end of study at 12 months. The 18 month data will be more robust and will be out shortly.
The FDA has said that they are very favorable to approving device if benefit and safety outweigh risk. This is the case in VBLOC, with 24.5% reduction in weight in obese people, great diabetic and hypertension benefits.
What patients did on placebo is really irrelevant since we know for a fact people cannot lose weight on placebo except for temporary mental power believing they had true device, once they are told device is fake they will remain FAT again however treatment arm will keep weight off.
This is easily APPROVAL FOR FDA PANEL.
I think results will be very good. The fact ETRM is very respectful of FDA to show them results first speaks volume and will encourage FDA to approve.
The FDA will simply look at the 24.4% number since every one in the world knows you do not lose weight by simply sitting down with a device. Placebo will be ignored as mental power does not work over the life of a person. On the basis of results 25% is great results.