The protocol prepared by the FDA is flawed and is to show why. In the protocol the FDA assumed that the VBLOC would hit 25% EWL loss and sham group 5% EWL loss hence a 20% target was put as realistic.
The assumption made by FDA in the protocol is wrong as sham group hit 15% where-as VBLOC did hit their 25% target.
Now whose fault is it? It is not ETRM as the protocol is designed by the FDA. If the primary assumption is incorrect the sham group (placebo) then the beginning comparative point cannot be maintained.
If the FDA had correctly put the placebo assumption at 15% then it would have required VBLOC only to hit 10% difference and, not 20%. The primary assumption was wrong. The rest of the report is fine.
I say approval for the following reason:
The Maestro Rechargeable System provides a new option for patients who are seeking
clinically significant weight loss.
As described in this document, the Maestro Rechargeable System is a safe and effective treatment option for obese individuals who have failed more conservative weight reduction interventions such as diet/exercise and pharmacotherapy, but are not able or willing to undergo more aggressive bariatric surgical options.
Obesity in the United States has reached epidemic levels. Two of every three adults in the U.S. are either obese or overweight. One of the most significant challenges facing clinicians in treating obese patients is the limited number of safe, effective, and acceptable treatment options.
You do see which market will be fulfilled, it is those who tried diet and failed, then took medication (pills) and failed but refuse bariatric surgery.
Now you can understand why oozhe22 is bashing here for OREX. Most people have tried diet and exercise but failed. People tried all types of medical products and failed. Most people refuse the bariartic surgery so there is NO OTHER SOLUTION.
Once FDA approves VBLOC which should be by mid September 2014 (3 months from FDA Panel date), I expect to hear that ETRM will go green light to Austrialia, Europe, Middle East and USA all at the same time.
ETRM has played it safe not wanting any data to interfere with FDA approval. A nice launch in all areas would be a good coordinated effect.
We know that Austrialia is saying there is demand, Middle East doctor said the same thing however he wanted 6 months of testing before going all out. USA will be faster.
A target of 100,000 patients around the world is attainable at $ 10,000 per device or $ 1 billion in sales.
That would translate into $ 3 per share or double today's stock price. At 10x earnings you get $ 30.
BRAVO!!!! I love your confidence. I can't say too much as people rather people labels on than hear my testimony. Most say I am a pumper for believing in the company.
I see what you see. The negativity will wear out as we move forward and as rotation into stronger hands is done from small investors to institutions. I saw this in RMTI, was so frustrating. It did this for 10 days and then bang up everyday from $ 3 to $ 16 in a matter of weeks.
Just read off the press wires and also on this board that ARNA CEO just sold 40% of his holdings all in one shot and, on a declining price hitting new lows. This is a sign that pills are flopping, following VVUS track record and delay in approval in OREX pills.
FDA is putting a hold on pills, it looks like. It don`t sell.
MARKET is now WIDE OPEN for ETRM....no competition at all. Knudson pretty smart, has built up the VBLOC licenses which will represent significant patent value as bidding war develops for ETRM.
ARNA and VVUS may also make a bid for ETRM.
Lots of interest here....
If Baker brothers is indeed loading up we will be over $ 5 in no time. Perhaps crew run dream is true.
There is nice accumulation as the base in set in the mid to low $ 1.50 level and the highs to the $ 1.60 level. As you can see we are going sideways and it is an accumulation phase.
The catalyst which will start the next run, and there will be a NEXT is the 24 month data which is extremely bullish. In the past ETRM would first show the data to FDA and upon their approval they would release it to the public. The 24 month data was shown to the FDA Panel on June 17th and it was bullish however FDA has not yet consulted it.
Assuming that ETRM filed this data with FDA by June 30th, which was after their celebration for obtaining panel approval, one can expect that FDA will look at these numbers within a 45 day period, say by August 15th before giving go ahead to release to the public.
If this date is say August 15th or close to it, we should be getting the data. Once numbers are known and which are strong, I expect spike in price as we begin RALLY into FDA approval process. Approval could either be late September or mid October 2014, hence a rally which begins August 15 could reasonably be expected as we walk into new highs and price in the possibility of a buyout.
The massive volume today was due to churning of shares between parties who colluded together to keep the price in check. I will give you an example as if I operated on my own. Say I bought 100,000 shares at $ 1.80 and then I sold them at $ 1.79, to rebuy at $ 1.80 to resell at $ 1.81, to rebuy at $ 1.80 to resell at $ 1.79. In doing this the volume would show 600,000 shares. If you look at this it can be misleading as it would tell you there was 600,000 shares for buyers matched by an equally powerful 600,000 shares by seller. It gives the impression that we are going no where.
Today that is what happened. A couple of firms who owned perhaps 500,000 shares to 1 million shares kept flipping them back and forth. The question is why would they do this?
One main reason is to discourage the longs and give the impression that no matter how many buyers there is an unlimited supply of shares or that something is wrong like naked shorts or that firm is selling shares. None of it is true. This trading will discourage a long and force them sell. It is another manner of shaking the tree.
Why would they shake the tree? Two reasons:
a) 8 million shorts needed to cover
b) There are large institutions whom want to load up without moving the price.
Luckily for us this churning process only lasts a few days until these white collar criminals have accomplished what they wanted.
Today's volume was 18 million however true figure is probably closer to 9 millions shares bought from longs who got scared and sold. The other 9 million was smoke screen, not real, back and forth with shares.
We will rally to $ 5. If only longs learned not to embark these games, stop losses, bear raid and now churning.
Thanks Zeeman for truly taking the time to feed us live with comments. It is almost like following a hockey game. From the tone of the comments since it began, first harsh then slowly toning it down to a realization that there is not much choice out there for obestity and FDA is seriously concerned. The panel have to live in reality too, pills don`t work, bariartic surgery is not for everyone. VBLOC fills a void and it is this void that ETRM is pushing real hard. Yesterday I predicted 8-1 in favor. Given comments earlier on thread that only 2 do not see device as effective I will say 7-2 in favor. A clear vote of confidence for FDA to approve. I am certain the 100 letters and public testimony had an effect. It is nice to hit protocol numbers in a perfect world but we live on earth in an imperfect world where obesity is a MAJOR problem. Anything that helps should be given a chance. I think the 5 year plan to put patients in a data bank for follow-up will soothe any concerns. Future generations of VBLOC can be tweeked in the future to become MRI compatable. CONGRATULATIONS LONGS for your confidence, your patient, your perserverance and endurance. Truly remarkable to be able to help people.
At the end of the article we notice the name of MEDTRONIC. Add 2 + 2 and you get MEDTRONIC buyout of ETRM. It is so obvious, here is the rest:
This project was supported by the International Neuromodulation Society, and was partially funded by a series of unrestricted educational grants from Medtronic Inc., St. Jude Medical Inc., Boston Scientific Corp., Nevro Corp., and Spinal Modulation Inc. No corporate entities had any direct input into the contents of this manuscript, or the conclusions of the collaborators.
When there is a news vaccum where we are in a holding period it is difficult to watch as stock gets trashed from one side to another, much as if you are making casino bets. There is no logic in buying or selling, simple emotions of trading within a core to generate some profits.
Fundamentally to make a bundle on any stock is to find one which is cheap in valuation compared to its market potential and earnings going forward. When you remove the noise of up and down, this is what I see:
- ETRM carries a valuation of about $ 90 million at this moment.
Question is: What is valuation of ETRM going into the future.
If approved and I say this is a rubber stamp procedure on ETRM, the valuation for a device company the first of its kind in a huge obesity market where there is a need, is going to be 10 times to 20 times it present market cap especially when one considers the type of earnings it will generate.
There are 200 million eligible patients and, even getting just 50,000 patients a year at $ 10,000 per device with 80% margins gives $ 500 million in revenue of which $ 400 million is profit. Removing some cost for administration and say you arrive at $ 300 million which gives earnings of about $ 2 to 3 per share and a $ 60 stock price.
So you can go ahead and sell based on the noise or you can do your homework like I did and LOAD UP while fools sell.
I had invested in RMTI at $ 3.75 last year around June I believe. They were to announce phase III results, which ended up being good. The stock opened at $ 5 and then collapsed to $ 4.45 a measily 70 cent increase while I was calling for double digits. Yes to some it will be pumping as usual. On that day I did like most of you, got fed up and sold. Too bad for me. Two months later stock was at $ 16 per share.
Why do I say this? Because I was calling for double digits on ETRM following FDA Panel due to enormity of the obesity market and that only getting crumbs from this would result in massive earnings per share.
The market has not reacted as I expected. That is true for today however I do believe we will be in for a RMTI type of rally. Which is a little every week for many weeks as institutions begin to load up and as small investors who trade around the core begin to exit. As we come closer to the magical $ 5 per share price I expect an explosion in price as many institutions who cannot buy under $ 5 will now be able to.
What is required for now is patience. The fact that we are early does not mean that we are not sitting on a goldmine. It means we are early. Why? Because maybe you see what I see and are frustrated it is not there yet however, if I have learned anything from my mistakes is that impatience is a great killer. It will cost you significant profit if you move on only to see ETRM finally rally.
The chart looks bullish and the volume is strong. A few more days like today and we will surge.
You don't prepare after approval. You prepare before approval. You lay your vision for your investors going forward and you show your confidence in your device. Hiding behind the curtains from the teacher is not a show of confidence.
When the trading doesn`t make sense it usually spells an opportunity. We had a bullish 6-2 FDA Panel vote which means FDA will approve. We are one step closer to marketing in a billion dollar industry. Yet here we trade at $ 100 million where trading today attracted $ 30 million in new funds and we barely move 10% when consensus was for a miss.
So what can be causing this order imbalance where there seems to be an unlimited supply of shares for sale.
a) MM want the $ 2.50 June calls to expire worthless it means millions in their pockets.
b) HFT keeping price low so 9 million shorts could get out
c) ETRM using $ 25 million ATM to raise funds
d) MM keeping price down so all large institutions and friends can load up.
Make no mistake, we are going up. It is a DELAYED rally. It happens to smaller stocks where price is lower and open to more manipulation. If we were in a $ 30 stock then it would not have happened.
Those who are long, keep your shares as we march towards $ 5 within a few weeks. There was nothing negative from yesterdays FDA Panel.
I am curious to know why CC was cancelled and why ETRM is not trumpeting the good news like other companies do. Must be BUYOUT....who knows maybe oozhee22 works for medtronic.
Dr. Knudson will provide an overview of EnteroMedics and its development and commercialization program for VBLOC® vagal blocking therapy.
August 14th Canaccord conference. Finally going to get details on commercialization side of the business as approval seems to be a done deal. This will give investors a VISION of the future and a reason to buy a high growth stock. Who knows perhaps this sell off was to permit those attending the conference to come and load up cheaply so Canaccord looks brillant.
I knew we were in for a great RALLY the moment oozhee22 showed up with his bashing. Company beat him to the punch, kept everything silent and last minute delivered a knock out punch so his firms couldn't load up secretly and now must buy on open market. Worst yet, they need to cover short position too.
This latest news at 36 months is blockbuster news as it ensures that VBLOC will be used by all doctors whom will sollicit among 200 million patients. It will be an easy sell now to patients with the trio combination.
Diebetics is a $ 50 billion market, Hypertension a $ 60 billion market and, Obesity is a $ 150 billion market.
I was saying double digits, might have made a mistake and it will probably be triple digits in a few years out.
Enjoy watching oozhee22 scramble as he doesn't know what else to do.
Approval most probably in September 2014 with this data.
I will give you my facts as to why this is going to get EASY APPROVAL and why we SOAR:
a) Obesity in the USA has hit epidemic levels 1 out 3 people is obese
b) The FDA is ALARMED at the steady rise in obesity rates despite diet pills
c) The FDA kept a board member on to vote despite conflict of interest as obesity is too important
d) The FDA was shown both efficacy and safety data in May 2013 and told ETRM to file PMA
e) FDA miscalculated plaecbo effect #$%$, it came in at 15% so hurdle for ETRM was too high
f) FDA letter of Sept 2013 asking for training post approval, which was to bring surgery SAE % down
g) Lerner (chief member of board) has stated that ETRM got a raw deal in protocol, hurdle too high
h) VBLOC resulted in 24% EWL compared to someone who is not on VBLOC (impressive)
i) VBLOC totally safe with only 3.5% SAE for device
k) Reality of diet pills is that they are rejected by doctors as patients have too many complications
l) Only alternative for obese people is stomach staple surgery and most reject procedure for risk
m) VBLOC fills a void which is after pills and before stomach staple surgery, no competition
n) VBLOC fills a void for elderly who cannot have stomach staple surgery due to complications
o) VBLOC fills a void young people who want to keep their stomach
p) VBLOC has kept 25% EWL at 18 months and, at 36 months in Austrialia.
q) There was not one single death in VBLOC compared with stomach staple surgery 1 in 300
r) ETRM has not raised any funds before Panel meeting which signals CONFIDENCE
s) OREX got rejected and is terrified of VBLOC, hiring paid bashers to knock confidence
t) Analysts are bullish on ETRM, average price target $ 5 or 300% from here.
u) Bear raid has caused good investors to flee to sidelines, once approved, they come back and we soar.
It is well know in life that without much risk there is not much reward. I have always felt confident in the approval process. VBLOC will help being down obesity.
Targeting the Vagus nerve is the new hot biotech idea and we are in the middle of this new innovation.
I remember once working on a file where one of my clients was quietly acquiring empty residential lots of land in the middle of nowhere. It seemed like he did not know what he was doing. Once he accumulated all private lots he was owner to a few acres in land. What people did not know was that a highway was going to be built next to this land. He then converted all of the land from residential to commercial. He went around and then shopped his land to a big anchor like an Walmart who was interested because the whole land came in one piece. When Walmart purchased part of the land he built a shopping center next to it using his land as collateral and obtain huge funds from the bank.
All to say that he spent $ 100,000 acquiring this land by using options only to the title, while he shopped it around. When deal was finalized he closed his sale price. At the end what you must know is that with $ 100,000 he was now sitting on a $ 10 million shopping center.
Why do I say this? Because it gives me the impression that ETRM is doing the same thing. Putting all approvals in order, in all countries without tarnishing it with any sales and encouraging another to buy it out.
My guess is that the buyer is MEDTRONIC.
They will be reading report and slides filed with FDA. Once done BUY orders come in. This will create huge momemtum, just like in RMTI which went up 500%. Institutions don't think like individuals do, they read and do their dd. If they like the stock, then firm decides we are purchasing 5 million shares over the next 60 days. If a few firms do this, we will have one heck of a rally especially now that the June 2.5 expired worthless.
I do believe we can all be in agreement including oozhee22 and shorts that VBLOC has met the SAFETY endpoint so this is not an issue in front of the panel.
I do believe we can all agree that FDA is seriously concerned with rise in obesity rates, especially after having approved diet pills which are not reducing these rates.
I do believe we can all agree that FDA wants to give consumers as many choices as possible in order to reduce obesity rate and tremendous health care cost burden especially when USA is trying to balance its budget.
The sole question before the FDA Panel therefore is as follows: Is Vbloc effect?
The response is yes it is however it did not meet the 10% threshold over placebo as defined in protocol.
The question becomes is the result achieved by VBLOC good enough? I think this is more of an FDA issue than a FDA Panel issue.
Everything is in the eye of the beholder. A woman can be obese and look ugly to one where-as another finds her slim and beautiful. The same is with VBLOC results.
This is how I would present the data. I would start by saying that obesity rates have been rising and it is common knowledge that if a person does nothing then either weight stays the same or goes up. I would include the VBLOC sham results and the VBLOC results however this is the comparison I would make:
Without VBLOC.............................With Sham Vbloc device....................With Active Vbloc device
I would tell the FDA Panel that in the real world people are not going to wear sham devices. The true test is between one with an active Vbloc device and another who has none. In this format we can say that VBLOC contributes to a 10% reduction in body weight, helps reduce obesity and healthcare costs.