buy2010: I guess you haven't been in the market long enough to observe swings in stock prices driven purely by black box trading. Some of the best money is made buying the dips as I did recently buying 6000 shares a tad below 1.17
I agree with your analysis. I do wish that Knudson had specifically stated the ADCOM date and panel name, instead of just saying "a spring panel date." I really think the horrible weather caused a lower than expected turnout in Boston.
At least Knudson did say that they also expected to launch in Europe, probably Germany, soon after FDA approval with the CE mark for weight loss. The next CE mark approval is expected for diabetes and later for hypertension. He also said they had a Euro distributor in place.
Unfortunately, Cowen attendance was hurt by bad weather. In fact, the person introducing ETRM thanked those who were able to make it because of the weather. Only one or two questions were asked in the Q & A. The positive takeaways were that Knudson said he anticipates FDA approval in the 2nd half of 2014 (no hedging there) and that cash is sufficient to carry the company into 2015.
"Gloria" is a movie from Chile that is in limited theatrical release and probably available on Netflix. In it a woman has a relationship with a man who has had gastric bypass surgery and lost about 100 pounds; however, he frequently has an unpleasant reaction after a meal, including nausea and throwing up.
If you had listened to me last June when I immediately sold all my CYTK after the R/S, you would have dodged a 25% haircut and made over 100% on the stock I flipped to and still own: ETRM. You guys vilified me and lost a big pay day.
The message board for ETRM has been inoperative for one week. I've looked for a specific Yahoo contact point to report the problem, but can find one. Anyone have a solution?
The ETRM release is very sketchy as it does not list which subpanel will review VBLOC. Check Exact Sciences(EXAS) press release to see the proper way:
(Dec 2, 2013)
Exact Sciences Corp. (Nasdaq: EXAS) today announced that the U.S. Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for the company's Cologuard stool-DNA-based, non-invasive colorectal cancer screening test on March 26, 2014. The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice.
(Feb 5, 2014)
Exact Sciences Corp. (Nasdaq: EXAS) today announced that the U.S. Food and Drug Administration has confirmed by notice in the Federal Register that its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will review the premarket approval application (PMA) for the company's Cologuard stool-DNA-based, non-invasive colorectal cancer screening test on March 27, 2014. The Federal Register notice can be found by clicking here.
Inns: Whitebox DID NOT buy 2,316,000 shares in 4th qtr. That's their holdings as of 12/31/13. Their SEC filing for the previous year ending 12/31/12 showed 2,458,000 shares.
I can't understand why only the Radiological Panel would review VBLOC as its radiation emitting risk must be very tiny compared to many other radiation emitting devices. The panel certainly can't vote on non-radiological matters. CFO Lea's very optimistic statement above may mean that the FDA has already decided to approve VBLOC after the rubber-stamp May 29 ADCOM.
I have a feeling that ETRM was surprised that the Radiological Panel and NOT the Gastroenterolgy Panel will review VBLOC. There appears to be some bad blood between the these two FDA specialists: (Sept 27, 2013)
Radiologists and gastroenterologists reviewing the latest research findings on the risks and benefits of computed tomography colonography (CTC) at a joint FDA advisory panel meeting September 9 stopped their squabbling over whether the newer technology is superior to optical colonoscopy (OC) to unanimously agree that the benefits of CTC for colorectal cancer screening outweigh the risks.
The agency brought together advisors from its Gastroenterology-Urology Devices Panel and Radiological Devices Panel to evaluate the benefits of CTC for screening of asymptomatic patients, including its potential to increase screening rates, and to look over the safety issues, including risks from radiation exposure and extracolonic findings.
Previously, gastroenterologists and radiologists have sparred over which technology is the best tool to find colorectal cancers – the second leading cause of cancer deaths in the US – in asymptomatic patients. But at the September 9 panel meeting, the medical advisors seemed ready to work together, based on the most recent research.
“This is a joint effort between radiologists and gastroenterologists. We are not at war with each other; we are here to serve the patient,” Douglas Coldwell, MD, PhD, a professor of radiology at University of Louisville, said during the meeting at FDA headquarters in Silver Spring, MD.
We are pleased that the FDA has decided to move the PMA application for our innovative technology forward
(Notice that Lea's language more strongly expects FDA approval. It's almost as though ETRM's advisors have a direct conduit to the ADCOM panel members and have already taken a straw vote in VBLOC's Favor).
We are pleased that the FDA has decided to move the PMA application for our innovative technology forward towards possible approval by scheduling an Advisory panel meeting to discuss the Maestro System. We very much look forward to presenting VBLOC Therapy to the panel members as we work to address the significant and widening gap in treatment alternatives for obesity and its associated diseases,” said Mark B. Knudson, Ph.D., EnteroMedics’ President and Chief Executive Officer. “We will continue to focus on thoroughly preparing for panel with the goal of delivering on the promise of this new treatment option to the millions of Americans who suffer with obesity.
As we announced early today, the U.S. FDA has scheduled an Advisory Panel meeting for May 29, 2014 to review our PMA application for approval of the Maestro System,” said Greg S. Lea, Senior Vice President, Chief Financial Officer and Chief Operating Officer. “Our primary focus remains on the regulatory process for VBLOC Therapy and preparing for a positive approval decision by FDA shortly after the Advisory Panel meeting.
Four reasons: 1) The ADCOM date was expected in March, now it is the end of May; 2) No conference call in conjunction with the earnings release and ADCOM announcement; 3) Zero sales for the 4th quarter; 4) The fear of a stock offering BEFORE the ADCOM panel-at least a 50/50 possibility.
Disclosure: I am long 21,000 shares with a current paper profit of about $7350.
Despite being down 4 cents at 3:04PM EST Barrons shows significant accumulation of 2.56 and positive cash flow into ETRM of $385,535.
From 1/2- 1/31/14, Wells Fargo reduced their % ownership from 5.36% to 4.86% and shares from 3,255,609 to 2,915 238. Just good profit taking.
Good news: If you look at the FDA's tentative panel dates for the first quarter 2014, ALL have converted into actual panel meetings. Thus, ETRM has a good chance of being scheduled for either the 3/20 or 4/1 gastro-urology meeting.
Bad news: Exact Science and Epigenomics are scheduled for March ADCOMS and months earlier issued press releases stating the tentative date given by the FDA.
The FDA keeps delaying giving ETRM an ADCOM date; in its defense, Knudson in the November fireside chat said that VBLOC was the first device of its kind being considered by the two FDA devices committees( I presume he meant gastroenterology-urology). Being first with a novel device is a guaranteed slowdown in the FDA review and approval process.
Neutral news: A post approval study will be required after PMA approval, but is unlikely to include an invasive sham arm, because of ethical considerations. I imagine that ETRM would just be expected to replicate existing trial results without significant side effects.
There is a recent example of just such a thing happening: Given Imaging bought by Covidien BEFORE FDA approval(which took a nervous 14 months).
In the 12-month Recharge Trial 155 patients received VBLOC implant and 78 sham implant(a 2-1 ratio), with 93% of participants reporting for their 12 month follow up. Fast forward to 18-month visit: 117 patients still on VBLOC and only 42 remained on sham. That means from day one to 18 months VBLOC had a 24.5% dropout rate vs. 46.2% for sham. 78% of the 18-month visitors are continuing in the random trial. One has to assume the continuees are overwhelmingly VBLOC patients, while sham patients drop out at a much greater rate.
Russell: The near govt shutdown put the FDA behind about 3 months. CEO Knudson is an old Medtronic pro who got VBLOC ok'd in Australia and Europe. FYI, the FDA welcomes trial info from Australia which ETRM has provided. The FDA got detailed 18-month data that was only skimmed over in the Dec PR. ETRM has been silent as they don't want to armchair quarterback the FDA. It should be noted the FDA just approved a glucose monitor for use in kids as young as 2! That's how desperate the FDA is to stem the diabetes and obesity tide. Unlike testosterone gels and Viagra, that have been abusively prescribed, the FDA knows that VBLOC will not be used off label or abused. If you're in at 2.33, you have already absorbed most of the downside risk; however, if you sell tomorrow and forfeit a 4 bagger that will be a big cloud for you.