There were no significant complications or untoward
Conclusion: Reversible vagal nerve blocking with the implantable
Maestro Rechargeable System results in medically
meaningful weight loss as well as improvement in diabetes
control in obese subjects with T2DM. Most significantly, the
benefits are sustainable to at least 36 months after implant
This is a rare instance where "Johnny Comes Latelys" get a super low buyin price. Notice as the stock is beaten down Barrons still shows moderate accumulation. Many small biotechs are being beaten down prior to another upward trajectory.
The two authors of the AMA opinion were unbelievably biased and misleading in their response. One expects this of Seeking Alpha writers, but not so-called healthcare professionals.
Wow! Trading volume today was the lowest in three months. You have to go back to 5/22 to find a lower volume day. Naturally, today's low volume enabled bears to erode the stock price, while Barrons still showed some continued accumulation.
oozhe: you are selectively picking negatives to make your case. Even uber-skeptic Alan Feuerstein is resigned to FDA approval, but hedges on future sales.
We were heading for a 1.19 or 4 cent drop, then the final NASDAQ close of 1.23 on 23,762 shares brought us even. Rarely have I seen a 4 cent spread between the official NASDAQ closing price and the last previous sale. Usually the spread is 1 or 2 cents.
Ade: Your perfect world scenario for VBLOC is outlandish. Meaningful insurance reimbursement won't kick in for at least a year. VBLOC's results are not strong enough to dislodge lapband and gastric bypass, but merely to offer a less invasive alternative. In addition to the sales staff there also needs to be doctor trainers and health support professionals, none of which comes cheap. Startup expenses are high and if ETRM goes it alone it will take easily three years to achieve profitability. ETRM's best bet is to partner or sell. My target price is $7.
Look at Spectrum's drug, approved a month ahead of their PDUFA date. The approval hurdle for medical devices with negligible cardiovascular risk is much much lower. Enteromedics and the FDA have already agreed on the post-approval five year monitoring. The complete 24-month data which the FDA now has confirms the widening gap favoring VBLOC vs. placebo.
In court docs for various high frequency trading desks it has come out that they have an unbelievable winning trading day 9 times out of 10. One HFT desks only had one losing day in a whole year! This is 2014, not 2004, and even market makers are getting burned by algorithm trading. Today ETRM was down 6% but had 1.67 uptick ratio and NET POSITIVE money flow into the stock of $101,603. Retail investors and micro cap funds lost today but the predators had their usual winning day.
This is why VBLOC will be approved:
"Obesity continues to be a major public health concern," said Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research. "When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition."
I agree. Investors forget that the majority of mathematically-derived trading systems promote a herd mentality whereby a downward or upward signal produces a pile-on effect. HF trading desks are in it to make money, not correctly value stocks; in fact, most of their money is made in overvalued or undervalued stocks/options.
rodtross: Why are you greatly exaggerating the "bonus/salary increase grab"? It amounts to approximately a modest $250,000 now and $89,000 in salary increases over a 12-month period. Today's employees expect money for a job well done and the timing was appropriate and a morale booster. ETRM's executive salaries are well in line with their peer group.
One can buy today at 20 cents below what director Friedman paid to add 11,800 shares to her family trust. Stock put into the majority of family trusts is kept there for long-term cap gains. Cathy spent 23 years with M & A giant Morgan Stanley and has a lot more inside info than we do.
Ade, to correct you there are other potential competitors on deck per FierceMedicalDevices:
USGI Medical, a California-based devicemaker focused on incisionless, endoscopic procedures for weight loss, reflux and advanced therapeutic endoscopy, said enrollment has been completed for a pivotal study to evaluate the company's POSE (Primary Obesity Surgery, Endolumenal) procedure.
Last October, the FDA gave conditional investigational device exemption (IDE) approval to USGI to begin enrollment. The company said it has signed up 332 patients at 11 U.S. sites for its ESSENTIAL trial. The study will be randomized and sham-controlled. Participating patients will use USGI's g-Cath EZ Suture Anchor Delivery Catheter to place tissue anchors across folds of tissue in certain parts of the stomach in order to reduce its size and ability to stretch to accommodate a meal.
"If the outcomes from the POSE procedure are positive and consistent with smaller trials, it could mean that tens of thousands of patients may have an incredibly compelling option to consider if they've struggled to lose weight with diet and exercise, but aren't candidates for or are not prepared to accept the risk of traditional bariatric surgery," Thomas Lavin, the lead investigator of the study, said in a statement.
Surgeons have already performed the incisionless, outpatient procedure on more than 2,000 patients, mostly in Europe, working through the mouth. Patients return to work, bandage-free, within two to three days. In one study conducted in Spain, patients who had the procedure reported feeling full quicker and less hungry between meals, the company said. A year after the procedure, those patients lost 62% of their excess weight, on average, or over 19% of their total body weight.
(Disclosure: I am a patient at Kaiser Permanente and I can tell you they push weight-control programs over surgical intervention. One has to fight to get treatments that other health plans routinely use. Fisher would catch hell from his Kaiser superiors if he wrote favorably about VBLOC. The fact is that intensive lifestyle programs work only for a small minority. Curbing hunger is what VBLOC does. LOL: In Citrus Heights, CA there is a gourmet bakery next to a Weight Watchers meeting. The bakery knows that diet-plan backsliders are some of their best customers: guilt promotes comfort eating).
David P. Fisher, M.D., of the Permanente Medical Group, Richmond, Calif., wrote in an accompanying editorial that several conclusions can be drawn from this study.
"First, vagal nerve blockade plus moderately intensive lifestyle counseling does not appear to be much more effective than an intensive lifestyle program. "