After a 5-month delay and a last-minute stock wobble, Pharming (AMS:PHARM) has FDA approval for its rare disease drug Ruconest. And with a U.S. partnership with Salix Pharmaceuticals ($SLXP) already in place, Pharming hopes to start racking up sales later this year.
The approval caps off a tumultuous week for Netherlands-based Pharming. On Tuesday, rumors of a negative FDA decision caused shares in Pharming to fall 37% in one hour, a period that included a temporary halt in trading. In an interview with De Telegraaf, CEO Sijmen de Vries denied that FDA had already rejected the application and the stock rebounded even faster than it had fallen. On Thursday morning the real decision was made public, giving Pharming and its investors cause for celebration.
Pharming shares opened up almost 40% on the strength of the approval, which will allow it to grow income from the drug.
According to E-Trade the top 10 owners own 43.5%, the top 20 own 48.4% and the top 50 own 51.3%. Ade, you do underestimate the ability of professional shorts(95% of outstanding short interest)to cover in a way that limits their hurt.
Crew: The market will not allow such a hyperbolic gain. I know about the past whereby DNDN soared twice and DVAX (which I owned at the time) soared from .26 to 2.60 in two days in Dec 2008. I would be happy to see ETRM hit $5 to $7 on my 20K shares. Understand that reimbursement will be slow in coming-which is why a partnership or buyout is the least dilutive option for ETRM.
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.
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.
Innsbrooklad: Yours is a most rational post. Rodtross and his ilk try to portray the modest bonuses and salary increases as Mt Everest, while they are just a molehill.
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.
(Ted presented at ADCOM and tweeted the proceedings for ConscienHealth. He spent 26 years with GSK)
1.Vagal Blockade. EnteroMedics won a mixed, but favorable, review for its Maestro VBloc device from an FDA advisory committee in June, lifting hopes that this technology would be making its way toward an FDA approval soon. The device works by intermittently blocking vagal nerve signalling for hunger, without requiring permanent alterations to gastrointestinal anatomy.
2.Gastric Balloons. Technology for gastric balloons has been available elsewhere in the world for some time, but not in the U.S., due to safety concerns with earlier versions of this technology. Newer versions, such as the ReShape Duo gastric balloon, may have overcome these concerns. ReShape Medical announced yesterday that they have filed an application with FDA to market this new gastric balloon in the U.S.
3.Intestinal Barrier. GI Dynamics is in the midst of a large clinical trial of their EndoBarrier device for the treatment of obesity at 25 sites in the U.S. The device prevents absorption of nutrients in the upper part of the small intestine and is believed to alter some of the neurohormonal signalling that plays a role in obesity.
4.Gastric Gel. Gelesis recently presented results of a clinical trial of their gastric gelling device at the annual meeting of the Endocrine Society. The Gelesis100 works by delivering gel-forming particles to the stomach, where it forms a gel and swells. In turn, this gel mass creates a sense of fullness and slows the absorption of food. In their 12-week trial, subjects who received the Gelesis100 device lost 6% of their initial weight, compared to those on placebo who lost 4%.
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.
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.
The Market is playing a cat and mouse game with ETRM, especially given this shortened trading week. If you can buy more as I expect the stock price to begin an upward trajectory next week.
Brad: You're math challenged. Your so-called "big piece of the cash pie" regarding bonuses only amounts to about 1-1/2% of cash.
Bloomberg interviewed Israeli medical device incubator co-founder and CEO of Rainbow Medical, Efi Cohen-Arazi. He mentioned another portfolio company Enopace Biomedical, which is working on a minimally invasive, implantable endovascular neuro-stimulator. Cohen-Arazi said neuro-modulation is "one of the hottest areas in medical devices today."
Startup electroCore demonstrated that its vagus nerve stimulator can prevent chronic migraine. The results of a small, sham-controlled study showed that the company's gammaCore device reduced the number of headache days per month and that those results improved over time.
The company presented the study results at the American Headache Society in Los Angeles, CA, from June 26 to June 29. The study ran over nine months at six U.S. sites. It had a run-in period of one-month followed by a double-blind comparison period of two months and an open-label phase of 6 months, in which all patients used the gammaCore device daily.
The 59 patients in the study reported more than 15 headaches per month in the three months preceding the clinical trial.
In the comparison period, patients were randomized to either a gammaCore or a sham device that was identical in appearance but did not stimulate the vagus nerve. The patients administered the gammaCore device on the right side of their necks, over their vagus nerve, three times daily. Each treatment consisted of two 90-second stimulations that were five to ten minutes apart.
During the two-month comparison, there was a decrease of 1.9 headache days per 28 days in the active group. No sham control patients experienced a significant reduction. During the 6-month, open-label phase, patients who had started in the active group showed a more than 8 day drop in headache days per month. The entire group experienced a 38% to 50% reduction in headache days.
kelvin: retail traders have to remove the phrase "someone must know something" from their lexicon. What "someone" knows is how to take your money. Case in point: OHRP. closed at 11.40 on 6/23, then bear raided on 6/25 as low as 6.86 on heavy volume. Today the stock is trading at 10.00 on positive news and the panicked sellers of yesterday are sick to their stomachs.