Reading between the FDA's briefing docs one senses a yearning to add something to fight the obesity epidemic. Here in Los Angeles the FDA's criminal investigation unit joined in a raid on a lap band mill that caused a number of deaths. The FDA has approved a number of drugs and devices with less than stellar numbers. ETRM's briefing docs seem to take its post-approval marching orders from the FDA, including a go-slow launch and heavy training and monitoring of VBLOC.
Morgan Stanley is a heavy hitter in M & A. They shopped Encysive when they were sold to Pfizer in 2007-08. In the SEC documents it showed MS sent out hundreds of pitch books, got about 80 responses and a dozen companies signed confidentiality agreements, with five serious bidders.
Believe me, Ms. Friedman has her ear to the rail and hears a money train coming.
Ade: Your appeal to longs is misguided. Trading bots control the price action, not a few thousand retail longs. You do have to tone down your excessive pumping. VBLOC should be a viable alternative to lap band and gastric bypass, but you wildly overstate future sales.
Ade: If VBLOC was a sure thing for in your words "easy approval", the FDA would not have called a panel, but approved VBLOC outright. The FDA is going to give A LOT OF WEIGHT to the panel votes. I'll stick with my 65% chance of FDA approval...for now.
BUY! This is a controlled walkdown, not a panic. Cathy Friedman is also a director at XNPT, but has only bought ETRM stock with her own money. One of Ms Friedman's co-directors at XENO is also a MS and Harvard alum.
Catherine J. Friedman has been a member of our board of directors since September 2007. She has served as an independent financial consultant to private and public companies in the life sciences industry since 2006. Prior to that, Ms. Friedman held numerous positions over a 23-year investment banking career with Morgan Stanley & Co., including Managing Director from 1997 to 2006 and Head of West Coast Healthcare and Co-Head of the Biotechnology Practice from 1993 to 2006. Ms. Friedman received a B.A. from Harvard College and an M.B.A. from the University of Virginia Darden School of Business. Ms. Friedman is a member of the boards of directors of EnteroMedics Inc. and GSV Capital Corp.
John G. Freund has been a member of our board of directors since 1999 and our lead independent director since July 2008. He has served as a managing director of Skyline Ventures, a venture capital firm specializing in healthcare companies since 1997. From 1995 to 1997, Dr. Freund was a managing director in the private equity group at Chancellor Capital Management. AMVESCAP plc acquired Chancellor Capital Management in 1998 and renamed the division INVESCO Private Capital. In 1995, he co-founded Intuitive Surgical, Inc. From 1988 to 1994, he held various positions at Acuson Corp. most recently as executive vice president. Siemens Corp. acquired Acuson in 2000. Prior to Acuson, Dr. Freund was a general partner of Morgan Stanley Venture Partners from 1987 to 1988. From 1982 to 1988, Dr. Freund was at Morgan Stanley & Co. where he was a co-founder of the Healthcare Group in the Corporate Finance Department. He received a B.A. from Harvard College, an M.D. from Harvard Medical School and an M.B.A. from Harvard Business School. He is currently a member of the boards of directo
Two of his recent posts on Marketwatch:
"Any interest in a $ETRM FDA panel live blog?"
"Funniest factoid about $ETRM If you implant a sham device, never turn it on, patients lose more weight in 1 yr than on $ARNA Belviq. "
Last year the company was predicting a 4th qtr 2013/1st qtr 2014 ADCOM. I think a possible reason the FDA postponed the ADCOM to 6/17/14 was to give the company time to show the 24-month data, which confirmed the melting away of the outsized sham effect.
The FDA is desperate to stem the obesity-diabetes epidemic. Medical device approval is a much lower hurdle than with drugs and the expectation is that VBLOC results will only improve with time.
Ade: Your arguments assume a "perfect world" for VBLOC. You remind me a bit of a TV evangelist, who when confronted by objectivity, replies "I have the faith-you don't." Your closing "it is simple math", is simplistic: reimbursement is a complicated process and physicians are slow to change(witness Australia). As an historical example, many doctors for years fought replacing radical mastectomy surgery with partial mastectomy surgery, long after conclusive results were in.
I am long 21,100 shares. Your pie in the sky projections might have some validity if VBLOC had achieved "super superiority" per the SPA. The FDA is giving ETRM the chance to make its case before an ADCOM panel of unknown sentiments.
Reverend Ade: You are making "faith-based" arguments like a televangelist, regarding VBLOC. It is in the public record that the majority of new product/device launches are NOT profitable for at least a couple of years or more, especially with micro companies building a sales and medical support staff from scratch. You completely ignore that VBLOC did NOT achieve "super superiority" per the FDA's SPA. ETRM is being given a chance to make its case before a panel. You conveniently forget that FDA briefing documents can be very pointed-the docs will not glorify VBLOC.
Are you a salesman? Your mentioning a "failure attitude" is a classic ploy used by motivational speakers trying to sell their "positive message" tapes. If by some chance VBLOC gets rejected by the FDA you will disappear from this board just like most pumpers on the CYTK board.
I am long 21,100 shares of ETRM.
And sell shares/warrants BEFORE the ADCOM meeting. From just filed prospectus:
" we intend to use the net proceeds from the sale of securities and exercise of warrants under this prospectus to continue work toward regulatory approval of our product in the United States, for commercialization efforts in the United States and internationally, to expand our operations and grow our research and development, product development and administrative operations and for other working capital and general corporate purposes."
kelvin: The panel ALWAYS votes THE SAME DAY on the voting questions posed by the FDA. Panel members are already quite aware of VBLOC and have read the FDA's briefing documents. Just like Supreme Court justices, 80% of the panel have probably made up their minds before 6/17, with a few on the fence.
(From the just filed 10Q-so much for Adeiflig's ridiculous profit projection for 2015):
Although we have received ARTG listings to sell our Maestro Rechargeable System in Australia and European CE Mark to sell our Maestro Rechargeable System in the European Economic Area and other countries that recognize the European CE Mark, resulting in our first commercial sales in 2012, we expect to incur significant sales and marketing expenses prior to recording sufficient revenue to offset these expenses. We expect our general and administrative expenses to increase as we continue to add the infrastructure necessary to support our initial commercial sales, operate as a public company and develop our intellectual property portfolio. For these reasons, we expect to continue to incur significant and increasing operating losses for the next several years. We have financed our operations to date principally through the sale of equity securities, debt financing and interest earned on investments.
innsbrooklad: Actually if you look at the filings and recent comments by management their current third party manufacturer is expected to continue on an increased production basis; in fact, ETRM has stated that they have been working with their third-party manufacturer for months.
What is significant is that the company received permission from the FDA to show the 24-month slide data SHOWING SUPER SUPERIORITY. Of course, the data is informational only, but it confirms what the FDA expected to see in the 12-month data: A REDUCED SHAM AFFECT.
rpk: This is a discussion board and I own 21,100 shares of ETRM. How many shares do you own? I've owned dozens of small company stocks in the last nine years and learned the hard way about unrealistic expectations. I turned a $75,000 paper profit into a $48,000 actual loss on Encysive Pharmaceutical in 2008. Wise "negative" posters have also sobered me up whereby I sold a stock and avoided a financial catastrophe.
This board is not a popularity contest. I'm not here to be anyone's friend but to glean ideas to make money and limit losses.
adeiflig: You have your head in the sand if you think the overall market and hedge funds and HFT desks have NOTHING to do with ETRM's stock price. I'm saying don't have pie in the sky stock price projections. I do agree that the risk at today's low price represents minimal risk; however, just as a bull market lifts most boats a weak stock market in May, June and July can act as a drag on the runup in ETRM's stock price.