Wed, Apr 16, 2014, 11:01 AM EDT - U.S. Markets close in 4 hrs 59 mins

Recent

% | $
Quotes you view appear here for quick access.

SPDR S&P Retail ETF Message Board

kirkydu 35 posts  |  Last Activity: Apr 4, 2014 1:07 PM Member since: Oct 30, 1998
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • Reply to

    A very Exact opportunity

    by oldguy794 Apr 4, 2014 12:27 PM
    kirkydu kirkydu Apr 4, 2014 1:07 PM Flag

    ooops, forgot about that, oh well.

    The Sample Collection Kit includes Instructions for use, a stool collection container with foldable plastic bracket, a preservative solution, a Protein Sample Tube with stool collection stick and buffer (for the hemoglobin component of Cologuard), and a mailing container. Patients collect a sample at home. The sample is sent to a laboratory for processing.

    Sentiment: Strong Buy

  • Reply to

    A very Exact opportunity

    by oldguy794 Apr 4, 2014 12:27 PM
    kirkydu kirkydu Apr 4, 2014 12:41 PM Flag

    thank you. 800 words is a tough pull on this one, but I tried.

    Sentiment: Strong Buy

  • Reply to

    I was a buyer Friday

    by kirkydu Mar 29, 2014 9:40 AM
    kirkydu kirkydu Mar 29, 2014 2:56 PM Flag

    maybe

    Sentiment: Strong Buy

  • The manipulation and "sell the news" was a good opportunity to buy. See Barron's today. EXAS is close to a big run.

    Have no idea what to think about Cramer, he's paid to flap his gums about everything on air so he does, his trade win percentage is almost exactly 50% according to a couple tracking sites - in other words flip a coin it's quicker.

    Sentiment: Strong Buy

  • Reply to

    Does big money trump logic?

    by mt_griffith Mar 27, 2014 8:43 PM
    kirkydu kirkydu Mar 27, 2014 9:14 PM Flag

    that's a decent portion of the puts, i.e. I even own out of the money puts in case of catastrophe.

    Sentiment: Strong Buy

  • kirkydu kirkydu Mar 27, 2014 8:31 PM Flag

    I control a 400k shares that aren't going anywhere but up. Giddiup.

    Sentiment: Strong Buy

  • Reply to

    SHORTS and EPI in BIG TROUBLE!

    by sailingaway82 Mar 26, 2014 6:13 PM
    kirkydu kirkydu Mar 27, 2014 10:19 AM Flag

    I also have been following EPI and read both company's FDA dox. I have considered investing in EPI, however, I have chosen not to because I think their science is very lacking. While they might get approval someday, I can't believe they get it now. Also, the market they are in is different than EXAS, it's much smaller. Their test is not for pre-cancers. By the time they detect, you are clearly stage 1 or further. People confuse the two tests as competitors. Too much risk in EPI for me.

    Sentiment: Strong Buy

  • kirkydu kirkydu Mar 24, 2014 9:10 PM Flag

    35 on calls, 65 on stock

    Sentiment: Strong Buy

  • Reply to

    looks like approval and 3 year interval

    by kirkydu Mar 24, 2014 12:26 PM
    kirkydu kirkydu Mar 24, 2014 12:32 PM Flag

    the post approval study is necessary to establish data over time in case there is a challenge product years from now. This data will provide the hurdle for any new technology. Exact would seem to be among the most likely to improve upon Cologuard.

    Sentiment: Strong Buy

  • 7.1 Overview of Proposed Post- Approval Study

    The DeeP-C trial was a point-in-time (cross-sectional) study that established Cologuard’s
    performance characteristics in the intended use population. However, no evidence was
    generated to understand how Cologuard performs over the course of a screening program
    in an average risk population. The purpose of the study is to collect longitudinal data on
    patients for whom Cologuard has recently been prescribed.

    The study objective is to collect longitudinal data annually on patients prescribed
    Cologuard over the course of 3 years and to assess the risk of CRC/AA among those with
    a positive Cologuard test at the third year of follow-up (T3) compared to baseline (T0).

    The primary endpoint for this study is to assess the risk of CRC/AA among those with a
    positive Cologuard test at the third year of follow-up (T3) compared to baseline (T0).

    The secondary objectives are to:
    • To evaluate the distribution of colorectal epithelial lesions (by Category) among
    positive Cologuard patients at T0 and at T3
    • To evaluate the predictive values of a positive Cologuard at T0 and at T3.

    Sentiment: Strong Buy

  • Reply to

    from this week's FDA documents

    by kirkydu Mar 24, 2014 12:03 PM
    kirkydu kirkydu Mar 24, 2014 12:16 PM Flag

    Secondary AA Sensitivity Comparison:

    The sensitivity to detect AA was 42.4% (321/757) for Cologuard and 23.8% (180/757)
    for PolyMedco FIT, resulting in a difference of 18.6%. The McNemar test p value was

    Sentiment: Strong Buy

  • Reply to

    from this week's FDA documents

    by kirkydu Mar 24, 2014 12:03 PM
    kirkydu kirkydu Mar 24, 2014 12:14 PM Flag

    Secondary CRC Sensitivity Comparison:

    In this population, CRC sensitivity was 92.3% (60/65) for Cologuard and 73.8% (48/65)
    for PolyMedco FIT, resulting in a difference of 18.5%. The one-sided 95% lower
    confidence bound on the difference was 8.0%. Thus, the secondary study objective that
    Cologuard was non-inferior to Poly FIT in CRC sensitivity was met with respect to FDA Executive Summary: Exact Sciences Corporation Cologuard™
    Page 20 of 65

    protocol-specified non-inferiority margin 5.0% because the lower bound 8.0% is greater
    than –5.0%.

    The two CRC sensitivities were significantly different, as indicated by a McNemar test p
    value p=0.002. Thus, Cologuard sensitivity can be declared superior to FIT sensitivity.
    FDA calculates that the difference 18.5% in CRC sensitivity has two-sided 95% CI
    [7.3%, 30.4%] (exact inference method).

    Sentiment: Strong Buy

  • Reply to

    from this week's FDA documents

    by kirkydu Mar 24, 2014 12:03 PM
    kirkydu kirkydu Mar 24, 2014 12:13 PM Flag

    Primary Analysis of Cologuard CRC sensitivity:

    Cologuard CRC sensitivity for CRC was 92.3% (60/65) with 95% one-sided lower
    confidence bound 84.5% (Clopper-Pearson method). Thus, the primary study objective
    of Cologuard CRC sensitivity greater than 65% and a 95% one-sided lower confidence
    bound exceeding 65% was met.

    Primary Analysis of Cologuard AN specificity:

    Cologuard AN specificity (categories 3-6) was 86.6% (7967/9198), with 95% one-sided
    lower confidence bound 86.0% (Clopper-Pearson method). Thus, the primary study
    objective of Cologuard AN specificity greater than 85% with a 95% one-sided lower
    confidence bound exceeding 85% was met.

    Sentiment: Strong Buy

  • Reply to

    from this week's FDA documents

    by kirkydu Mar 24, 2014 12:03 PM
    kirkydu kirkydu Mar 24, 2014 12:10 PM Flag

    from FDA generated doc exec summary:

    The primary performance measures of the study were Cologuard CRC sensitivity and
    Cologuard advanced-neoplasia (AN) specificity. The sponsor chose to exclude AA’s
    (category 2) from the specificity calculation, considering these to be positive outcomes
    since they are treated during colonoscopy. In this executive summary, the per protocol
    sensitivity is called CRC sensitivity and the per protocol specificity is called AN
    specificity (which excludes CRC and AA).

    The primary objective for Cologuard CRC sensitivity was a 95% one-sided lower
    confidence bound exceeding 65%. The primary objective of Cologuard AN specificity
    was a 95% one-sided lower confidence bound exceeding 85%.

    Sentiment: Strong Buy

  • Reply to

    from this week's FDA documents

    by kirkydu Mar 24, 2014 12:03 PM
    kirkydu kirkydu Mar 24, 2014 12:07 PM Flag

    As a well-controlled investigation, the DeeP-C pivotal clinical study, constitutes valid scientific
    evidence, as defined in 21 C.F.R. §860.7(c)(2), upon which the agency can make a determination of
    the safety and effectiveness of the device. The pivotal study results demonstrate a reasonable
    assurance that Cologuard is safe (as defined in 21 C.F.R. §860.7(d)(1)). The probable benefits to
    health from use of the device for its intended uses and conditions of use, when accompanied by
    adequate directions and warnings against unsafe use, outweigh any probable risks. In addition, the
    study results demonstrate the absence of unreasonable risk of illness or injury associated with the
    use of the test for its intended uses and conditions of use. Exact Sciences also believes that the
    pivotal study provides a reasonable assurance that Cologuard is effective (as defined in 21 C.F.R.
    §860.7(e)(1)) because, in a significant portion of the target population, the use of Cologuard for its
    intended uses and conditions of use, when accompanied by adequate directions for use and
    warnings, provides clinically significant results.

    Sentiment: Strong Buy

  • Reply to

    from this week's FDA documents

    by kirkydu Mar 24, 2014 12:03 PM
    kirkydu kirkydu Mar 24, 2014 12:06 PM Flag

    As a well-controlled investigation, the DeeP-C pivotal clinical study, constitutes valid scientific
    evidence, as defined in 21 C.F.R. §860.7(c)(2), upon which the agency can make a determination of
    the safety and effectiveness of the device. The pivotal study results demonstrate a reasonable
    assurance that Cologuard is safe (as defined in 21 C.F.R. §860.7(d)(1)). The probable benefits to
    health from use of the device for its intended uses and conditions of use, when accompanied by
    adequate directions and warnings against unsafe use, outweigh any probable risks. In addition, the
    study results demonstrate the absence of unreasonable risk of illness or injury associated with the
    use of the test for its intended uses and conditions of use. Exact Sciences also believes that the
    pivotal study provides a reasonable assurance that Cologuard is effective (as defined in 21 C.F.R.
    §860.7(e)(1)) because, in a significant portion of the target population, the use of Cologuard for its
    intended uses and conditions of use, when accompanied by adequate directions for use and
    warnings, provides clinically significant results.

    Sentiment: Strong Buy

  • Reply to

    from this week's FDA documents

    by kirkydu Mar 24, 2014 12:03 PM
    kirkydu kirkydu Mar 24, 2014 12:06 PM Flag

    In addition to meeting the primary and secondary endpoints of the study. Cologuard consistently
    demonstrated strong performance across cancer stages and lesion sizes. In particular, Cologuard
    sensitivity was particularly strong for Stage I thorugh III CRC, stages that are most likely to respond
    well to treatment and have the highest survival rates. In addition, Cologuard sensitivity for AA
    represented a clear advantage over FIT, particularly for larger adenomas. Additionally, Cologuard
    sensitivity for adenoma with carcinoma in situ/high grade dysplasia, lesions at high risk of developing
    into CRC, was 69.2% compared with 46.2% for FIT.79 Cologuard also provides an advantage in
    sensitivity for detection of serrated lesions, a lesion that has been increasingly linked to CRC
    development. Cologuard sensitivity for serrated lesions was 43.0%, compared with 5.1% for FIT.

    Sentiment: Strong Buy

  • Reply to

    from this week's FDA documents

    by kirkydu Mar 24, 2014 12:03 PM
    kirkydu kirkydu Mar 24, 2014 12:04 PM Flag

    Cologuard
    demonstrates a clinically meaningful sensitivity (92.3%) for CRC and specificity (86.6%), and the
    DeeP-C study powerfully demonstrating that Cologuard is statistically significantly superior to FIT
    testing for detection of both CRC and AA.

    Sentiment: Strong Buy

  • "In summary, the study demonstrated that Cologuard was highly sensitive and specific for CRC. The
    analysis also demonstrated that Cologuard was superior to a currently available FIT product for both
    CRC and AA detection. Considering the risks compared to the benefits of screening with Cologuard,
    Exact Sciences believes that Cologuard provides an additional, important screening option for CRC
    and AA. All information to date demonstrates a favorable risk-benefit profile for Cologuard."

    Sentiment: Strong Buy

  • Reply to

    Chance to exit

    by imriteyernot Mar 11, 2014 8:26 AM
    kirkydu kirkydu Mar 11, 2014 5:18 PM Flag

    I've been in on this company for years. They can't compete with Tesla or even other battery companies. The will dilute again or go bankrupt or do a sell-under. I told people to get out before it dropped a lot last time. I'm telling you again. Get what you can out of this. Their tech has no future. It's 40 year old tech that has reached its physical limit.

    Sentiment: Strong Sell

XRT
82.03+0.46(+0.56%)10:59 AMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.