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Spencer Osborne

 
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  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    dax....

    This year....in concept...This is from the latest conference call on Nov 12th:

    "Since our FDA-PMA advisory committee meeting in June, we have been working with the Food and Drug Administration toward an approval decision on VBLOC therapy. As many of you know, the FDA is currently reviewing our Pre-Market Approval application or PMA for the Maestro Rechargeable System as a treatment for obesity. Our dialog with the FDA continues to be open and productive, and as we have previously announced, we expect a decision to take place this year.

    In June, our clinical and scientific findings with VBLOC therapy were evaluated and discussed at a Gastroenterology and Urology Devices Panel Advisory Committee meeting. We were very pleased that the panel voted eight to one in favor of safety and six to two, that the benefits of the Maestro system outweigh risks with one abstention.

    While the efficacy vote was four to five against, the critical safety and overall benefit risk questions received strong positive votes. This outcome is particularly important, in light of the evolution of FDA's views on benefit risk paradigms for obesity devices.

    In a paper authored by Dr. Lerner, Deputy Division Director in FDA's Office of Device Evaluation and his colleagues in surgical endoscopy in 2013, the authors state, if a device fails to meet the predetermined primary endpoints of the trial, but has a good safety profile, the agency will review the submission in its entirety and make a final determination based on both benefit and risks. While the FDA is not bound by a panel's recommendation, it does take that recommendation into consideration, when reviewing a Pre-Market Approval application."

    Not a slam dunk, but not a total miss either. The company did hire a Chief commercial officer in the past couple of weeks, which would seem to indicate that they are planning on a positive outcome.

    "Brad Hancock will join the Company as Chief Commercial Officer effective November 17, 2014. Mr. Hancock has more than 30 years of experience in the medical device field serving in senior commercial operations and executive roles for St. Jude Medical and Medtronic, among others."

    "Brad brings to EnteroMedics a valuable blend of commercial and strategic marketing expertise, with a deep understanding of the sales and marketing functions both domestically and internationally," said Mark Knudson, President and Chief Executive Officer. "I am pleased to welcome Brad to EnteroMedics at this pivotal time, as we prepare for the launch of VBLOC vagal blocking therapy for obesity in the U.S., and build on our commercial strategy in other key markets around the world."
    Nov 19, 2014. 09:36 AM | Likes Like |Link to Comment
  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    Jakes....

    The 52 week low is about a buck vs. a high of about $2.60. I think there is room to move with approval.

    The company does need to do some housekeeping on its website. Their link toi the recharge study is broken, and that is not good. Someone looking to invest in this company will want to see that data. Broken links can give an indication that someone is not paying attention. It can scare investors away.

    http://bit.ly/1t4FTwL

    The press release section allows for access to archives, but does not give easy access to stories in the current year.

    http://bit.ly/1t4FTMY

    The most recent information on the publications section of the site is 2011...over 3 years ago. This is an indication that the website has been unattended to since then. Again, not a good practice when you are trying to get up and running and attract investors.

    The newsroom tab has a most recent date of 2011 as well. Not good.

    The "Careers" tab has no current openings. If a company is not actively hiring, the "careers" tab should not carry the prime website real estate at the top right of the tabs bar. If they are no hiring, move that tab to the bottom of the page.

    These are simple changes that should be made as soon as possible. I know that they do not relate to the product itself, but they do reflect on the company. At this stage this company wants to attract investors. Investors will be cautious, and a website that is not up to date is a flag of sorts that does not instill confidence. This company is still a very speculative play and little things like this can scare people away.
    Nov 19, 2014. 09:09 AM | 1 Like Like |Link to Comment
  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    Jakes....

    I believe that there is a better than decent shot at approval and that it will happen in this year. There is a space for this device in the market. In my opinion anyone with a BMI of 35 or more that is considering surgery may opt for the less invasive vbloc. Not trying to hype it.

    As for the riff-raff.....it's being addressed.

    Cheers
    Nov 18, 2014. 08:08 PM | Likes Like |Link to Comment
  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    Galo.....

    People need options. Pills can work for some. A minor surgery such as vbloc is a solution prior to major surgery. Ultimately the best course of action is one determined by the doctor and the patient. Unfortunately, with insurance the way it us, the best course may not always be viable. Even more unfortunate is that ACA has decimated people in so many ways that it is a travesty.
    Nov 18, 2014. 06:53 PM | Likes Like |Link to Comment
  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    Aris....

    That comment by Kevin does seem off base. Bariatric surgery is not going to vanish. It is unfortunate that there exists some very inflated expectations. Inflated expectations usually bring about disappointment. Further, setting unrealistic expectations usually leads to the street not taking a company or its equity seriously. Hopefully there are more people with more realistic expectations.
    Nov 18, 2014. 06:50 PM | Likes Like |Link to Comment
  • The Naive Arena Investor [View instapost]
    Tune....

    Let me offer truth and clarity.

    1. I do not care whether someone buys or sells.

    2. Some investors are not in a position to take advantage of a tax loss. A financial advisor can help someone understand and comprehend whether a tax loss sale is worth while. In my case it was VERY worth while

    3. I do not care about the short position. It is most likely hedged plays.

    4. the short position is pretty much the same as it has been for months.

    5. Miss an opportunity to participate in upside????? Really? A tax loss sale like I did only requires a 30 day wait. What waiting game? As long as the price was under $4.91 or so I was in positive territory. As it happened, I had no need to wait.

    You are full of bad assumptions and should likely try to avoid simplyfying things because it is clear that this type of financial move is something you do not understand
    Nov 18, 2014. 05:44 PM | Likes Like |Link to Comment
  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    Jakes....

    I do not hold bags very often. I keep a close eye and intend on selling the spike (if it happens). If not, no worries...I simply sell....I have room to spare
    Nov 18, 2014. 04:28 PM | Likes Like |Link to Comment
  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    Jakes....

    Bought ETRM a while back. I dabble in companies that are near a potential approval. The exception was OREX, which never hit my buy-in price leading up to the potential june approval (ultimately it was pushed to October). At that stage, the air was out if the baloon on orexigen, so I did not consider it a possible double.

    I look at this one as a potential spike on an approval, a sale of a good chunk to take profits, and the ability to sit on some "free" shares. I like t do the "free share " strategy.

    With arena I sold half at a 45% profit...not wite getting to the "free share" stage. I added a small amount just prior to the ceo sale. I sold the balance at about $3.80 to grab the tax benefit. I bought back in with more shares by utilizing tax savings. I will add a bit more if the price is in the right place.
    Nov 18, 2014. 02:53 PM | Likes Like |Link to Comment
  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    Kevin...

    You say that this article lacks all of the key points. That is your opinion. You gave expressed your key points on several articles around the web. It just so happens that your key points lack accuracy.

    Do you remember saying this?

    "Pills going nowhere. All these pills are really pathetic, low efficacy, way high sides considering the low efficacy, zero chance of approval in Europe, in Europe they don't approve this kind of concoction, they never did"

    ETRM is a very easy multibagger

    * extremely low valuation
    * no competition in its segment, that's between pills and bariatric
    * less expensive than pills, one time $7k vs $2.4k every year forever
    * much better EWL than pills, 24-25%

    ETRM Maestro Device will put bariatric surgery (250k a year) in the trash bin. VBLOC is
    * Cheaper
    * Much Less invasive, 30-45 minute surgery, out same day and implanted through a minimally invasive laparoscopic procedure.
    * No removal of any organs
    * No change in eating lifestyle
    * Totally reversible
    * Works with your schedule as you adjust device
    * Extremely safe, less than 10% SAEs vs 40%
    * ETRM holds patents hence is a MONOPOLY

    and the best part is that ETRM doesn't necessarily need to conquer to world. Just 20k procedures a year or just the forecast of it in a couple of years equates to more than 15 times the current share price."

    You state that pills cost $2,400 a year forever. This is a gross exaggeration.

    You say pills must be taken forever. A gross exaggeration

    You say that pills have low efficacy. Interesting but not accurate, because, about half of those that take pills will see the same 10% body weight loss that vbloc delivers. Remember, percentage of body weight lost is the apples to apples comparison.

    You say that there is no lifestyle change with vbloc. A gross exaggeration. Each study included lifestyle modification, as will the label if vbloc is approved. Read the data.

    You say this is worth $20 in two years. You have also had other valuations over a month or so. I seem to recall yo saying $30 at some point.
    Nov 18, 2014. 12:18 AM | 2 Likes Like |Link to Comment
  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    Pat....

    I hope that thisays off well for you.
    Nov 17, 2014. 10:10 PM | 1 Like Like |Link to Comment
  • EnteroMedics May Enter The Obesity Space - What Does It Mean? [View article]
    citi....

    IMO $5 may be a bit aggressive, but if FDA approval happens in the near term, it would make $5 a possibility by early 2016 or so. My plan is likely selling a good chunk on an approval and then sitting on free shares while I assess the uptake in the market.
    Nov 17, 2014. 04:55 PM | 1 Like Like |Link to Comment
  • Belviq Weekly Sales Come In Flat [View article]
    Jonas....

    An ETRM article

    http://seekingalpha.co...
    Nov 17, 2014. 04:46 PM | Likes Like |Link to Comment
  • Belviq Weekly Sales Come In Flat [View article]
    Jonas....

    Slow down. Let's keep this real simple.

    Do you agree that the first recommended step is lifestyle modification?

    Do you agree that the second step is a pharmacological step (pills)?

    Do you agree that the third step is surgery?

    Do you agree, in concept, that vbloc is step 2.5 (for lack of a better way to place it).

    Any logical person agrees with everything above.

    Thus, a person that is considering step 3 would have taken or considered step 2.5, should have tried step 2, and should have tried step 1.

    A person considering step 2.5 should have tried step 2, and should have tried step 1.

    A person considering step 2 should have tried step 1.

    This is a very simple progression. I know you have an extreme desire to put VBloc into step 2, but it simply is not there.

    The recharge study required people to be between a BMI of 40 and 45 OR a BMI of over 35 with a comorbid condition.

    The Empower study required people to be between a BMI of 40 and 45 OR a BMI of over 35 with a comorbid condition.

    The vagal blocking study required people to have a BMI of over 35

    Now, let's apply LOGIC here.

    Do you think that the FDA is going to approve this device for use in people with a BMI of under 35 when there is not a single study on that group of people? Logic dictates that the answer is no.

    I realize that some of what I am telling you may be the first time you heard this, and therefore may be difficult top digest because your beliefs were something different.

    So, lets review some numbers for perspective

    We will use a 5'8" person this time.

    Ideal weight is 165

    At 177 (BMI 27) they are eligible for pills if they have a comorbidity. They are not eligible for vbloc

    At 184 (BMI 28) they eligible for pills if they have a comorbidity. They are not eligible for vbloc

    At 190 (BMI 29) they eligible for pills if they have a comorbidity. They are not eligible for vbloc

    At 197 (BMI 30) they are eligible for the pills. They are not eligible for vbloc

    At 203 (BMI 31) they are eligible for the pills. They are not eligible for vbloc

    At 210 (BMI 32) they are eligible for the pills. They are not eligible for vbloc

    At 216 (BMI 33) they are eligible for the pills. They are not eligible for vbloc

    At 223 (BMI 34) they are eligible for the pills. They are not eligible for vbloc

    At 230 (BMI 35) they are eligible for the pills. They are now eligible for vbloc if they have a comrbidity

    At 236 (BMI 36) they are eligible for the pills. They are now eligible for vbloc if they have a comrbidity

    At 243 (BMI 37) they are eligible for the pills. They are now eligible for vbloc if they have a comrbidity

    At 249 (BMI 38) they are eligible for the pills. They are now eligible for vbloc if they have a comrbidity

    At 256 (BMI 39) they are eligible for the pills. They are now eligible for vbloc if they have a comrbidity

    At 262 (BMI 40) they are eligible for the pills. They are now eligible for vbloc even with no comrbidity

    A person that is 5'8" can be eligible for pills from 12 pounds overweight to any amount.

    A person that is 5'-8" can be eligible for vbloc from 71 pounds to any amount.

    From 12 pounds to 71 pounds is essentially territory that vbloc can not touch but pills can. Are you starting to see things that you did not see before?
    Nov 17, 2014. 01:23 PM | Likes Like |Link to Comment
  • Belviq Weekly Sales Come In Flat [View article]
    Jonas.....

    So you doubt that we live in a perfect world, but you have a certainty that people will be standing in line around the block to have a surgical procedure done.

    OK
    Nov 17, 2014. 12:30 PM | Likes Like |Link to Comment
  • Belviq Weekly Sales Come In Flat [View article]
    Jonas...

    We do not live in a perfect world. We do however have a medical system with certain standards. An assumption that doctors will bypass other "remedies" and go straight to vbloc is not a very sound assumption.

    Use your logic
    Nov 17, 2014. 12:29 PM | Likes Like |Link to Comment
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