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Mike Havrilla  

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  • Green ETF Investors Hopeful as Obama Takes Office [View article]
    Climate Exchange (CXCHF) is the only stock or fund I would buy of the entire green, alternative energy, or carbon credit space as a spec play on the expansion of carbon credit trading in the U.S., China, and other countries outside of Europe where it is already established. Rick Santelli just mentioned Climate Exchange on CNBC as the topic of discussion at the Chicago Merc amongst the traders based on its potential for expansion in the U.S. market now that Obama is in office.


    On Jan 22 05:53 PM danno wrote:

    > PWND and PZD are both probably better choices than what this guy's
    > recommending. I mean that Elements stuff is quantitative gobbledygook
    > masking vapid strategy.
    Jan 23, 2009. 03:03 PM | Likes Like |Link to Comment
  • Updated Calendars of FDA Decisions and Clinical Trials [View article]
    This pertains to publishing the articles in a medical journal, but if the companies are public the results must be disclosed to shareholders in the form of a press release.


    On Jan 22 11:51 PM Cynthia wrote:

    > I just read an article on NewsInferno.com that negative results from
    > clinical trials are often not published or experience serious publication
    > delays. Scary.
    Jan 23, 2009. 09:13 AM | Likes Like |Link to Comment
  • Updated Calendars of FDA Decisions and Clinical Trials [View article]
    Thanks, I just added AVNR to the clinical trial calendar for 3Q09:
    Pivotal Phase 3 Results Expected 3Q09 for Zenvia (dextromethorphan/quin... + pending Ph3 trial for neuropathic pain



    On Jan 22 08:59 PM JG08 wrote:

    > Please include Avanir Pharmaceuticals (Nasdaq: seekingalpha.com/symbo...).
    > Data from their confimatory phase 3 study is expected in 3Q09
    Jan 22, 2009. 09:05 PM | Likes Like |Link to Comment
  • Updated Calendars of FDA Decisions and Clinical Trials [View article]
    DSCO is included on the bottom calendar of pending FDA decisions and I have profiled it in previous articles with PDUFA date of 4/17/09 for Surfaxin Class II review after latest resubmission last year.


    On Jan 22 09:18 AM Ardeis wrote:

    > Please include Discovery Labs which has a Class I review of Surfaxin
    > due on or before April 21st I believe.
    Jan 22, 2009. 09:22 AM | Likes Like |Link to Comment
  • Create Your Own Diagnostics ETF [View article]
    I know their valuation is largely based on prospects for Feraheme as a treatment for iron-deficiency anemia, but included AMAG since they have a diagnostic imaging business. Also HealthShares Diagnostics actually held AMAG as position when they rebalanced their funds last October:
    biz.yahoo.com/indexuni...

    The new stocks being adding to HHD are:

    Abaxis
    Affymetrix
    AMAG Pharmaceuticals
    AngioDynamics
    Enzo Biochem
    Given Imaging
    Merit Medical Systems
    Neogen Corp.
    Nighthawk Radiology Holdings
    Quidel Corp.
    SonoSite
    TomoTherapy
    TOPCON Corp.
    Jan 21, 2009. 09:56 AM | Likes Like |Link to Comment
  • Exact Sciences Plays Hard to Get with Sequenom [View article]
    Not to mention the CNBC Pumping of SQNM over the past month:

    Insight on the biopharma sector, with Peter Kolchinsky, RA Capital Management partner and CNBC's Mike Huckman - of course RA Capital already has about one-half of its entire portfolio invested in SQNM!

    For a warm-up, first get SQNM recommended on Mad Money last month:
    www.cnbc.com/id/158402...

    Then follow up about a month later with a SQNM - CNBC Pumping 101 Video on 1/13/09:
    www.cnbc.com/id/158402...

    I guess we will find out shortly if the end of month results for SQNM are a sell on the news event or not, but the market cap exceeding $1.5B does not leave much margin for error.
    Jan 17, 2009. 03:48 PM | Likes Like |Link to Comment
  • Exact Sciences Plays Hard to Get with Sequenom [View article]
    With SQNM affirming their $1.50 per share exchange offer earlier this week; it creates a new support level for EXAS following the Board's rejection on Monday while it pursues a better deal for shareholders.

    The other deal being pursued while likely involve a substantial (e.g. $20M-$30M) upfront payment for licensing EXACT's prenatal diagnostic patent portfolio, and the Company also holds the rights for the development of an automated, FDA version of their sDNA colorectal cancer screening test since LabCorp (LH) only holds the right to the homebrew version, marketed since last July as ColoSure.

    A NY Times report summarizes the results of a study published in the medical journal, Annals of Internal Medicine, which concluded that colonoscopies may actually prevent 60%-70% of colorectal cancers [CRC] rather than previously believed rate of 90% for the test. While colonoscopies are still effective at preventing CRC and will continue to be widely recommended and used; the study highlights limitations of the procedure – especially in the detection of right-sided lesions, which account for about 40% of all cases of CRC.

    Sensitivity results of 82% were already published last summer for EXACT's V2 sDNA technology, while the next-generation sDNA test (V3) boasts 92% sensitivity and has shown the potential to detect 86% of precancerous adenomas. Currently, only 24% of the 90M eligible patients in the U.S. are compliant with CRC screening recommendations and there is clearly an unmet medical need for an effective, non-invasive CRC screening test for the average-risk population which people will actually use.

    If LH was willing to pay $30M upfront for rights to the homebrew sDNA CRC screening test; the prenatal diagnostic patents + the FDA version of the sDNA test should each be able to command a similar figure. Since EXAS has been pursuing strategic alternatives for a long time already, the SQNM offer is likely to expedite any pending deal(s) being considered by the Board while drawing attention to EXAS and creating a new support level at $1.50 per share.
    Jan 16, 2009. 08:08 PM | 1 Like Like |Link to Comment
  • Trading FDA Decisions: Cypress Bioscience Soars, A Trio of Buys [View article]
    K-Fine's strategy is to invest in biotech ETFs such as IBB + XBI in addition to companies such as DNA rather than trying to pick riskier small/micro-cap stocks, which is a reasonable strategy since she manages other people's money and has to invest a lot more capital than you & me trading online

    Below is a link to my blog for the new healthcare indexes that I follow for investing/trading ideas:
    www.etfinnovators.com/...

    Also, I track the cos. with pending FDA or clinical trial decisions, including over 140 such ideas at the link below:
    www.etfinnovators.com/...

    Jan 16, 2009. 01:39 PM | Likes Like |Link to Comment
  • Trading FDA Decisions: Cypress Bioscience Soars, A Trio of Buys [View article]
    Jazz Pharma (JAZZ) is starting a 2nd Phase 3 trial for JZP-6 (sodium oxybate) Expected NDA Filing by EOY-09 + Phase 3 Results Expected Mid-09
    Jan 15, 2009. 09:05 AM | 1 Like Like |Link to Comment
  • A Closer Look at Sequenom's Offer for EXACT Sciences [View article]
    Insight on the biopharma sector, with Peter Kolchinsky, RA Capital Management partner and CNBC's Mike Huckman - of course RA Capital already has about one-half of its entire portfolio invested in SQNM!

    For a warm-up, first get SQNM recommended on Mad Money last month:
    www.cnbc.com/id/158402...

    Then folloow up about a month later with a SQNM - CNBC Pumping 101 Video on 1/13/09:
    www.cnbc.com/id/158402...

    On Jan 13 07:29 AM User 148361 wrote:

    > Such a worthless, one sided pump. Scumbag.
    Jan 13, 2009. 09:50 PM | Likes Like |Link to Comment
  • A Closer Look at Sequenom's Offer for EXACT Sciences [View article]
    There's no need to pump this one - the Board of EXAS spelled it out directly in the PR last night that a better deal for shareholders is in the works or SQNM can come back with a higher bid if they are interested


    On Jan 13 07:29 AM User 148361 wrote:

    > Such a worthless, one sided pump. Scumbag.
    Jan 13, 2009. 09:43 AM | Likes Like |Link to Comment
  • Bio-Pharma, Diagnostics Buyout Binge Begins [View article]
    Check out my other article today for JAV - also it is one of my nine stock picks for this year and included in those articles

    I don't follow RPRX as closely, but it is included in the clinical trial calendar I just posted on my blog:
    www.etfinnovators.com/...

    Mike


    On Jan 11 09:05 AM y3maxx wrote:

    > Hi Mike,
    >
    > Great list to reference with.
    >
    > ...Repros Therapeutics (seekingalpha.com/symbo...) nor
    > Javelin Pharmaceuticals (seekingalpha.com/symbo...) don't
    > seem to appear on any list.
    >
    > Repros is in new 52 week high territory with two drugs in late stage
    > development and Javelin has two Ph3 pain drugs in development. <br/>
    >
    > Both have cash, no debt with overhead costs controlled stringently.
    >
    >
    > tia
    Jan 11, 2009. 09:14 AM | Likes Like |Link to Comment
  • Updated FDA Decision Calendar: Five Decisions Before Year-End [View article]
    Ulysses Benjamin Dover, I guess we will found out by the end of April if your analysis is also faulty

    If you were long going into the BLA filing/acceptance you already made a lot of money - I have no position long or short in the past and no plans for a position either way in the future - only watch NFLD as part of my FDA calendar of pending new drug decisions


    On Jan 05 11:14 AM Ulysses Benjamin Dover wrote:

    > Mikey, once again your analysis is faulty. Like Feuerstein you miss
    > the central issue of what Polyheme is. It is NOT supposed to be a
    > substitute for blood when blood is available (not this version anyway,
    > butt someday), it is for when somebody is bleeding out and there
    > is no blood available. There is a substantial need for such a product,
    > hence why the FDA walked this product through a controversial clinical
    > trial and now has granted fast track. To boot, the military wants
    > this product.
    >
    > The important data is NOT a direct comparison of how Polyheme compares
    > to blood as a substitute for blood, but how close to being like blood
    > for when there is a need for blood but no blood is available. In
    > the prior study it was found that people who were going to die from
    > bleeding out, had about a 70% survival rate with minimal adverse
    > events v. getting saline. It really is simple deductive reasoning
    > that if I am going to die from bleeding out because we can't get
    > me a transfusion in short order and am offered a 70% chance at survival
    > using Polyheme, I'm using the Polyheme.
    >
    > This product will receive a limited approval, the stock will rise
    > and the company will be bought by a large well funded company that
    > can develop and market the product further. Of course, part of that
    > deal will be Dr. Gould to get a great paying job, but that's fine,
    > we'll see a price north of $6 (extrapolate near term profit potential
    > just on U.S. remote location trauma usage) in 2009.
    Jan 6, 2009. 04:55 AM | Likes Like |Link to Comment
  • 139 Names on ETF Deathwatch [View article]
    AirShares (ASO) Carbon Fund seems destined for the list even though it just started trading 12/15/08:
    www.etfinnovators.com/...

    iPath Global Carbon ETN (GRN) has been trading about six months now with little in the way of net assets or trading volume and I see it made the list
    Jan 4, 2009. 07:40 PM | Likes Like |Link to Comment
  • Affymetrix Remains a Value Trap Until Its Results Improve [View article]
    AFFX should do well at least early in 2009 since it is a small-cap that got crushed in 2008, although it has already rebounded by over 50% from the low around 2 bucks and used about half of its net cash to buy Panomics. Don't think I would hold it going into the next earnings release as lately they have missed estimates and lowered guidance. If the market sustains recent positive momentum, you can buy about anything and make money -- especially the small, high beta names that got beaten up last year. I haven't bought any AFFX since there is no near-term catalyst expected, although the huge cash position means they will be around long-term and could get acquired at some point.
    Jan 2, 2009. 06:15 PM | Likes Like |Link to Comment
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