Friday, March 3, 2017

Top IT Minds Flying to Twitter and about to Descend in Droves, Change is being Orchestrated~


CEO and co-founder Jack Dorsey has never felt more pressure to Act than Today. He must initiate and oversee the boldest operational changes to date. The changes must be Twitter-centric and accelerate global brand recognition especially during any Live event whether it's related to the NFL or PGA in the U.S. or Cricket matches in India, the platforms must be user friendly with Twitter-centric competitive barriers to entry. 





If the Creator of Twitter is taking aggressive Corrective Actions, Interviewing and Hiring the best IT and Marketing brainiacs and Rewarding them with large upfront bonus money / recruitment checks in addition to very fat salaries and stock option grants if they Program like Eddie Snowden or exceed high internal Quarterly and Yearly Sales targets as Twitter has the potential to Monetize an astronomical number of local and global events that are in a state of constant Churn and Repetition.

There always are Exciting and often controversial Live events Live events Ahead of Us whether planned or not. The World Cup of Soccer, are you paying Attention @Jack, comes around every 4-years, the hotter than ever U.S. Presidential election fights that come around roughly every 3.3-years as primaries are no longer to be taken lightly. Did you hear that Bernie and Ted? The wise CFO's usually play the Expectations game with WS analysts by guiding Lower, perhaps from 6% - 10% lower than internal Sales goals and then hopefully over-delivering when actual results are posted. This type of financial management of numbers almost always works to Gap share Price higher which makes for more positive news headlines and keeps shareholders interested. The opposite would be to always report as expected / guided which is often a screaming Tell of a mature company, unable and uninterested in the Hypergrowth phenomenon that trailblazing / new sector companies do experience, and it all starts with a demanding and forward-thinking CEO who cares ... perhaps like Elon Musk? As much as we know many hate green anything, POTC believes TSLA's batteries will gain faster traction than 75% of WS analysts estimate. 


We feel that Jack Dorsey has never been more committed to witnessing a Twitter turnaround. We predict that Dorsey is not waiting any longer but at this very moment taking full Advantage to leverage Twitter's global brand recognition that was seeded on March 21, 2006 - hence the company will turn 11-years young in just over 2-weeks from this writing. Could the "double 1's
", 11-year Anniversary mark 1 or 3 paradigm shifting events that were "In Twitter's cards" since 2006 and Dorsey is Wiser or luckier than most shareholders now believe, we think Yes. The latest chain of negative events happened for a reason, the Timing is ripe for @Jack to take his Social Media experiment to the next level of Monetization. 

We've read nearly every opinion article over the last couple of months, weeks, and especially days and we can't recall another $10B market weight equity, social media or unrelated, that was painted with such an ominous tilt with the main argument being current Valuation. And were there not a large pack of Netflix (NFLX) Bears created by a very similar Valuation thesis that fingered unsustainable cost of content? NFLX carried a market cap of $10B for quite a long time just as TWTR Today. And how about Yelp! (YELP), wasn't that stock Marked for a Death Spiral the day Zuckerberg decided to aggressively compete, putting YELP into a penalty box that would force such fast and deep margin erosion shares would plunge into the single-digits within 2-Quarters if not sooner. FB wouldn't make this power play for any short-term financial benefits. The Financial strangulation of YELP would have a much greater chance if YELP were to best 100% of the WS estimates on both Top and Bottom lines.


FB's larger and more addicted User base along with its slightly more impressive breadth of services and hungrier Executive brass creates a fulfilling environment Loop - an open-net opportunity for cross-marketing and Up-selling YELP's clients anything 'n everything they exhibit interest in via texts, FB comments, posts, and now those high-quality, crisp Instant Messenger voice calls have stripped the new generation of their Privacy - Hadoop-poop-poop

But who cares about Privacy "as long as they're not doing anything illegal" is the piss-poor Excuse from the socialized media's corporate Brasses and we're not going to play 

too much longer inside any box Adulterated by 'American' hypocrites who Impress many with their billions while 80% railed against Trump. Wise forward-thinkers could argue that prostitutes and their pimps make a more honest Buck than the Executive Snoops who reward their underlings with tens of millions in dollars or stock grants if their coding abilities reveal them to be Top Notch Internet Marketing Peepers - Hadoop-poop-poop ~ poop

And IF Privacy should only be a concern to people doing illegal things how would this picture be Explained




The Zuck-meister!

Regardless of the twisted politics at these social media companies, we think TWTR's worst days have passed and we expect the stock to rally above $20.00 within 1-month and that's with modeling for a 5% - 12% broad market correction Upon Us Now. Friday the 10th should be one bloody day for bulls, yet as Traders we need Volatility so we will be cheering when that correction finally hits. As for TWTR, who better than Dorsey to demand hard line Operational Improvements. Dorsey co founded Twitter back in 2006 - so when the calendar books turn to the March 21st page (in 17-days), the stock will celebrate its 11th anniversary. In human years Twitter is just a tweener who just a few years back was experiencing teething pain. Tweet Tweet~


And it's absolutely normal for even the most Loyal of shareholders, inside the TWTR flock, to be Angrier than Ever. And the Timing appears more forceful when we juxtaposed improving Price Action next to the Titanic bad opinions of the supposed Experts, WS anal-ysts.



Snapchat's (SNAP) hugely successful IPO yesterday, (March 2, 2017) directly related to its 250% larger market capitalization than TWTR, in addition to other brain bleed ratios like Price/Sales have forced CEO Dorsey to Implement Plan 001-B ASAP.





We expect very expensive yet very necessary Marketing and Programming talent that will Monetize Live feeds by leveraging new software applications and platforms to land at Twitter within days. not weeks.

So then will Dorsey's $7M stock purchase just 1-week ago be considered lucky or calculated? We argue both lucky and calculated and say no more.
A confusing future is how many felt about the stock after its earnings release just 2-weeks ago, yet @Jack #Seer did not panic 'n fold but stepped up and bought $7M of stock even as he knew Snapchat was about to compete for social media dollars because its IPO was Imminent. 

SNAP's nearly 300% fatter market cap, as Trading resumed on Friday, was the last broken wing Dorsey ever wanted TWTR to suffer. Live Tweet Monetization is Coming to a gadget in your pocket. 

Just Hashtag It~

Thursday, March 2, 2017

EXACT Sciences (EXAS) "Cup 'N Handle" Chart is Bullish

Greetings to All POTC readers,


2-yr weekly Illustrates a "Cup 'n Handle" - Imminent Breakout Expected~






Friday, January 1, 2016

2016 U.S. Presidential Process is Creating Several Excellent Trading Setups...



Public Policy Uncertainties regarding



Energy

Environment

Healthcare




Republican Debates
  1. January 14, 2016
  2. January 28, 2016
  3. February 6, 2016
  4. February 13, 2016
  5. February 26, 2016
  6. March 10, 2016
Democratic Debates
  1. January 17, 2016
  2. February 11, 2016
  3. March 9, 2016
General Election Debates
  1. September 26, 2016
  2. October 4, 2016 (Vice President)
  3. October 9, 2016
  4. October 19, 2016


Republican frontrunners Ted Cruz and Donald Trump




Democrat frontrunners Bernie Sanders and Hillary Clinton  



Thursday, December 24, 2015

Chipotle's (CMG) E. coli Outbreaks are Causing Long-Term Damage to their Brand/Reputation and We Predict > 70% of WS Analysts will be Forced to Downgrades Sales & EPS Forecasts through at Least 2017


Frustratingly, there is no good precedent for Chipotle’s food safety issues,” wrote RBC Capital Market analyst David Palmer. But citing Taco Bell’s past troubles, he forecast a year of sales declines for Chipotle.

Barclays analyst Jeffrey Bernstein has noted Chipotle’s recovery may take longer than other chains that have been hurt by foodborne illnesses, because social media has increased people’s awareness of such incidents.

He also noted that Chipotle’s “Food With Integrity” slogan makes the E. coli (fecal contamination) cases 
all the more damaging.

We clipped this piece from an article written by Candice Choi from The Associated Press.


We believe the fallout for Investors is far from Over 




Thanks for Reading, 
POTC~

Merry Christmas 2015 and a Healthy 2016 to All Our Loyal Partners and Readers since 2008 !




Tuesday, December 22, 2015

Gross Domestic Product (GDP) is the Broadest Measure of Business Activity, It Includes every Sector in the U.S. Economy

Released on 12/22/2015 @ 8:30am ET for Q3, 2015
PriorConsensusConsensus Range
Real GDP - Q/Q change 2.1%2.0%1.7% - 2.2%
GDP Price Index - Q/Q change 1.3%1.3%1.3% - 1.3%
Recent History of the GDP Indicator
Econoday consensus is calling for a 0.1% drop in the 3rd estimate for Q3, illustrated above. Apart from Inventories, where changes are often difficult to interpret, Demand indications in the 2nd estimate were positive with final Sales up 2.7%.



  • Real GDP rates are quoted Quarterly or Annually and measure how much the economy has Grown or Contracted over a period in time. Quarterly GDP rates are often volatile so many economists place greater emphasis on Year over Year changes since this data set paints a more stable picture.
Data Source: Haver Analytics

Thank You,
POTC~


Wednesday, December 9, 2015

"Psychology of the Call" : Ophthotech (OPHT) has caused 2 Giants to Curtsy, Fovista is the next Franchise Maker~

"Psychology of the Call" : Ophthotech (OPHT) has caused 2 Giants to Curtsy, Fovista is the next Franchise Maker~

Ophthotech (OPHT) has caused 2 Giants to Curtsy, Fovista is the next Franchise Maker~

On May 19, 2014, OPHT entered into the largest deal in the history of biotech with Novartis. The total deal is worth $1B with upfront payments, $330M already realized, in addition to milestones ahead. 

The most impressive nugget is not the $1B Headline number but the potential for Billions in yearly Sales and Income if the Phase III results/data proves:

  • Fovista has the power to Reverse some blood vessel damage wet AMD (Age-related Macular Degeneration) is responsible for, thus great hope for Preventing or Delaying patients from going blind. Imagine being on the brink of blindness but being able to avoid the horror because of the novel properties of Fovista. 
  
From OPHT's 10-K, dated March 14, 2014, click here for entire page
We further believe that the administration of Fovista in combination with anti-VEGF drugs in patients with wet AMD may cause regression of neovascularization and may inhibit subretinal fibrosis more effectively than anti-VEGF monotherapy. We believe that Fovista may provide meaningful added benefit in the treatment of wet AMD regardless of which anti-VEGF drug is administered in combination with Fovista.



CEO David Guyer's confidence in the life changing potential of Fovista is clear during every presentation. Click here to analyze Guyer's most recent live appearance:
Oppenheimer conference on Tuesday, December 8, 8:35am ET.

REGN has not joined forces with the 2 Giants, Novartis and Genentech but this could change or else REGN risks that OPHT chooses Genentech's Lucentis and the fallout on Sales of Eylea could have disastrous consequences. We'll be paying close attention to every Investor Day and earnings call REGN is involved in from this day forward.  

After sending a bullish take on REGN in the $45.00 range in 2011, before Eylea was approved, we feel that OPHT is in a similar situation but isn't getting enough respect perhaps because Fovista's Phase III top-line data won't be released until Q4, 2016. 

We're assigning a 67% probability that this drug is truly Special and will graduate to blockbuster $1B Sales status within 1-year. Guyer has become more aggressive of late trying to explain why and how Fovista is on the doorstep of changing lives of patients and shareholders. Please play back the Oppenheimer conference with link provided above and you'll make a sounder Investment or Trade thesis. Our most profitable trades were the direct result of spending Time & Effort researching, but especially listening to the Psychology of the Call(s). 

Eyelea and Lucentis will have combined Sales of about $5B in 2016. Fovista just has to show the same Phase II 62% improvement in reading acuity in Phase III and we estimate that $500M in U.S. Sales will be easy within 5-Quarters post approval. And with the likes of Novartis and Genentech ex-U.S. Sales should ramp quickly right out of the gate.   

But if Fovista proves that it's capable of turning back the clock on a certain percentage of damaged blood vessels and stop subretinal fibrosis more effectively than the mono therapies Eylea and Lucentis then OPHT will have a tremendous opportunity to Sprout a Ophthamology Franchise from a single molecule. 

Guyer would be vindicated and would be able to highlight the ineffectiveness of Wall Street analysts like Terence Flynn with Goldman Sachs who issued a Sell rating and $45.00 price target on August 7, 2015.



We remain suspicious of Terence Flynn's motivations behind his Sell rating, here's a link that explains.

If at the end of 2016 we witness that paradigm shift data then OPHT should fast become the only biotech that is marketing a wet AMD drug with ability to Prevent people from going blind. 

OPHT's current $2.4B market cap would Gap to new highs which few Investors are positioned for even with a small percentage of their aggressive portfolios.

REGN's market cap is 60X larger than OPHT's as of today. Though attaining REGN's size is unlikely no matter what the top-line data shows in 2016, we dearly wanted our loyal readers to understand that there is a Special nugget to look for when that day of reckoning finally comes.

We believe OPHT could carry a $4B market cap in 2016 ahead of what will be super exciting and very positive Phase III results.


1-year chart has been very bullish in 9 out of the last 12-months
 


Happy Christmas and Happy Hanukkah to One & All !
POTC

The IPO was impressive when you review; some extra credit information. If you had to guess after reading the piece above, was Goldman part of the syndicate team with OPHT? Answer will be found below.

The New York-based ophthalmics company, founded by former Eyetech Pharmaceuticals executives David Guyer and Samir Patel, priced its IPO late Tuesday, and sold 7.6 million shares at $22 apiece. Those figures mean Ophthotech ended up raising a whopping $167.2 million from the offering—a number that could jump even higher if its underwriters add the 1.14 million additional shares they have the option to buy at the IPO price over the next 30 days.
Ophthotech’s haul is more than double the $85 million the company initially sought to raise from public investors when it first outlined its IPO in August. Further, Ophthotech upsized the offering and boosted its projected range twice. On Sept. 9, it contemplated selling 5.72 million shares at $16 to $19 apiece. Then, early Tuesday, it amended its IPO prospectus again, estimating that it would sell 7.6 million shares at $19 to $20 apiece. It’ll begin trading on Wednesday on the Nasdaq under the symbol “OPHT” with a market capitalization already exceeding $600 million.
Novo A/S (28.65 percent) was Ophthotech’s largest stockholder prior to the IPO, followed by SV Life Sciences (26.80 percent), HBM Healthcare Investments (15.21 percent), and Clarus Ventures (13.57 percent).
Morgan Stanley, J.P. Morgan Securities, Leerink Swann, and Stifel, Nicolaus & Co. are the company’s underwriters.
Why all the interest? Investors are clearly intrigued by Ophthotech’s approach to treating the wet form of age related macular degeneration, a condition in which abnormal blood vessels grow in the macula—a part of the retina—and leak behind the eye, leading to distorted vision and potential blindness.
The market for wet AMD has evolved from laser therapies to a group of drugs injected into the eye that work by blocking the vascular endothelial growth factor (VEGF) that researchers believe causes the condition to worsen. Roche/Genentech’s cancer drug bevacizumab (Avastin) is often prescribed off-label for wet AMD, but the other anti-VEGFs—ranibizumab (Lucentis, also from Roche/Genentech) and aflibercept (Eylea, from Regeneron) have also emerged as big successes.
Ophthotech is trying to tweak the wet AMD treatment paradigm. While anti-VEGFs only stop abnormal blood vessels from continuing to grow, Ophthotech has created a drug that targets a different protein, platelet-derived growth factor (PDGF), which scientists believe may cause those blood vessels to recede when added to the regimen. Ophthotech’s plan, then, is to have patients get separate injections of both its anti-PDGF (a drug it hopes to market as Fovista if approved by regulators), and an anti-VEGF, during each visit. Though Ophthotech isn’t the only company trying this type of approach—Waltham, MA-based startup Kala Pharmaceuticals is developing an anti-VEGF/anti-PDGF combination as well, for instance—the Ophthotech drug is the furthest along in development.
Ophthotech’s big IPO raise will help bankroll a late-stage clinical trial, in which it’s hoping to show that patients getting injections of both its anti-PDGF and ranibizumab fare better than those getting injections of the Roche drug alone. Ophthotech will start that big Phase 3 by the end of the year, and plans to have the first top-line data from that study in 2016. Ophthotech owns worldwide rights to the drug.






 

Tuesday, December 1, 2015

Gilead (GILD) is a Sell, We Believe Shares will be Trading Below $100.00 as the End of 2015 Nears

  • GILD's HCV Sales slid 2% from Q3 2014 to Q3 2015 and some analysts believe Sales peaked back in Q1.
  • Potential rate hike and subpar Q4 earnings season should fuel an equity swoon and GILD won't be immune.
  • With the high cost of drugs becoming a Political issue as the debates heat-up, GILD will probably be forced to lower their prices or chance greater media scrutiny and reimbursement hurdles from insurers.

 


     
 
 
  • 1-year chart signals Bearishness over the next several weeks. GILD has failed to hold its 50, 100, & 200-day averages and more negative Directional tells if we glance at the 'Williams %R' and 'Relative Strength' studies

     
  • SELL GILD is our professional blogging conclusion. 




 
 

If you'd like to know our #1 biotech to Buy & Manage from today thru 2018 please send us an email and we'll forward the details: Psychologyofthecall@gmail.com
 
Happy Christmas and a Healthy 2016!
POTC~

Monday, November 23, 2015

Chipotle Mexican Grill (CMG), the Ramifications of an Ongoing E.coli Outbreak Analyzed...

A Larger Number of Chipotle restaurants still Unsafe to Dine at due to the Harmful Bacteria "Shiga toxin-producing E.coli O26 (STEC O26)" that 1st Appeared on the West Coast but just recently We Learned that this Bacteria has been Linked to Illnesses Across the Entire U.S. from the Midwest to New York. 

What Motivated Ms. Katie Reilly with Reuters to Write a Complimentary Piece about Chipotle on Saturday is Disturbing, yet Odd things Occur during Times of Crisis when Billions of Dollars and Brand Reputation are on the Hook. Katie's Jovial Piece Claimed that She spoke to some Chipotle Customers and found that they are Undeterred by the E.coli Outbreak, telling her that their Main Reason for Eating the Food is because It's Fresh. Asinine and Bordering on Highly Suspicious Media, Buzz? You Decide by clicking here.

The Food Source(s) that is now Responsible for Umpteen Violent Illnesses Remains a Mystery. Until the Scientists from the U.S. Centers of Disease Control (CDC) Identify the Food/Menu Item/Source that is Causing this Nightmare Outbreak, 45 Victims in 6 States Currently with 16 having being Hospitalized, Chipotle's Reputation is Likely Plummeting from Day to Day.

Saturday's Bogus Press Releases that Many will Interpret as an Underhanded Deception in Order to somehow Try to Hoodwink the Public is Troubling. 

And a Critically Important Nugget No Wall Street Analyst has even Touched is Whether Chipotle's Food Outbreak is being Caused by  Contaminated (Accidental), or Adulterated Food (Wilful/Wanton Misconduct).

If We Find Out that Chipotle's Food was Adulterated by some Evil Doer(s), this would Spark a Criminal Investigation and perhaps Cause Diners Who Decided to Turn their Backs to become more Sympathetic in the long-run and come back.

The Healing Curves of Contamination versus Adulteration will be very Different for All Involved with Chipotle. Yet Regardless, Investors Should Remain Pained for the next Several Quarters at least as the company Admitted that Same Store Sales Growth would Slow to the Single-Digits in this Quarter and that Guidance was Given Before the E.coli Outbreak News was Disseminated.  





Thanks for Reading,
POTC~     



 

Sunday, November 22, 2015

16 People Who Ate at Chipotle had to be Hospitalized out of the 45 Who Fell Violently Ill in an Ongoing, Multistate (6), and Mysterious Outbreak Saga. Scientists from the CDC Are still Attempting to Identify the Food Source Responsible and Whether It's being Spread by 'Accidental' Contamination or 'Wilful' Adulteration, the Bad Bacteria is Shiga Toxin-Producing E.coli O26

  • Consumers should contact a health care provider if they recently became ill with diarrheal symptoms after eating at a Chipotle Mexican Grill restaurant.
  • The ongoing investigation has not identified a specific food linked to illness.
  • CDC will advise the public if specific steps are identified that consumers can take to protect themselves.
  •   
  • 3 additional states have reported people infected with the outbreak strain of Shiga toxin-producing Escherichia coli O26 (STEC O26) since the last update.
  • 45 people infected with the outbreak strain of STEC O26 have now been reported from a total of 6 states: California (2), Minnesota (2), New York (1), Ohio (1), Oregon (13), and Washington (26).
  • The epidemiologic evidence available at this time suggests that a common meal item or ingredient served at Chipotle Mexican Grill restaurants in several states is a likely source of this outbreak.
  • The investigation is still ongoing to determine what specific food is linked to illness.
  • CDC will advise the public if specific steps are identified that consumers can take to protect themselves.

  • Highlights

    • Read the Advice to Consumers »(http://www.cdc.gov/ecoli/2015/o26-11-15/advice-consumers.html)
    • CDC, the U.S. Food and Drug Administration, and public health officials in several states are investigating an outbreak of Shiga toxin-producing Escherichia coli O26 (STEC O26) infections.
    • As of November 19, 2015, 45 people infected with the outbreak strain of STEC O26 have been reported from 6 states.
      • 16 ill people have been hospitalized. There have been no reports of hemolytic uremic syndrome and no deaths.
    • The epidemiologic evidence available at this time suggests that a common meal item or ingredient served at Chipotle Mexican Grill restaurants in several states is a likely source of this outbreak.
      • 43 (96%) of 45 ill people interviewed reported eating at a Chipotle Mexican Grill restaurant in the week before their illness started.
      • The investigation has not identified what specific food is linked to illness.
      • Chipotle Mexican Grill is assisting public health officials with understanding the distribution of food items served at locations where ill people ate and this work is ongoing.
    • Investigators are using whole genome sequencing, an advanced laboratory technique(http://www.cdc.gov/amd/), to get more information about the DNA fingerprint of the STEC O26 bacteria causing illness.
      • To date, 10 STEC O26 isolates from ill people in Washington (9) and Minnesota (1) were found to be highly related genetically to one another.
    • CDC and state and local public health partners are continuing laboratory surveillance through PulseNet to identify additional ill persons and to interview them.
    • Consumers should contact a health care provider if they recently became ill with diarrheal symptoms after eating at a Chipotle Mexican Grill restaurant.
    • CDC will advise the public if specific steps are identified that consumers can take to protect themselves.

    November 20, 2015

    Case Count Update
    CDC is only reporting ill people that have been confirmed by PulseNet(http://www.cdc.gov/pulsenet/) as being infected with the outbreak strain of Shiga toxin-producing Escherichia coli O26 (STEC O26). Forty-five people infected with the outbreak strain of STEC O26 have been reported from 6 states. The majority of illnesses have been reported from Washington and Oregon. The number of ill people reported from each state is as follows: California (2), Minnesota (2), New York (1), Ohio (1), Oregon (13), and Washington (26).
    Among people for whom information is available, illnesses started on dates ranging from October 19, 2015 to November 8, 2015. Ill people range in age from 2 years to 94, with a median age of 22. Fifty-eight percent of ill people are female. Sixteen (36%) people reported being hospitalized. There have been no reports of hemolytic uremic syndrome and no deaths.
    This outbreak can be illustrated with a chart showing the number of people who became ill each day. This chart is called an epidemic curve or epi curve. Illnesses that occurred after October 31, 2015 might not be reported yet due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of 2 to 3 weeks. Please see the Timeline for Reporting Cases of E. coli Infection(http://www.cdc.gov/ecoli/reporting-timeline.html) for more details.
    CDC and state and local public health partners are continuing laboratory surveillance through PulseNet to identify additional ill persons and to interview them.
    Investigation Update
    CDC, the U.S. Food and Drug Administration, and public health officials in several states are investigating an outbreak of Shiga toxin-producing Escherichia coli O26 (STEC O26) infections.
    The epidemiologic evidence available to investigators at this time suggests that a meal item or ingredient served at Chipotle Mexican Grill restaurants at several states is a likely source of this outbreak. The investigation has not identified what specific food is linked to illness. Chipotle Mexican Grill is assisting public health officials with understanding the distribution of food items served at locations where ill people ate and this work is ongoing.
    State and local public health officials are interviewing ill people to obtain information about foods they might have eaten and other exposures in the week before their illness started. Forty-three (96%) of 45 people interviewed reported eating at a Chipotle Mexican Grill restaurant. The investigation is ongoing to identify common meal items or ingredients causing illness.
    Investigators are also using whole genome sequencing, an advanced laboratory technique(http://www.cdc.gov/amd/), to get more information about the DNA fingerprint of the STEC O26 bacteria causing illness. To date, whole genome sequencing has been performed on STEC O26 isolates from 9 ill people in Washington and 1 ill person in Minnesota. All 10 isolates were highly related genetically to one another. This provides additional evidence that illnesses outside the Pacific Northwest are related to the illnesses in Oregon and Washington.
    Updates will be provided when more information is available.

    Tuesday, October 6, 2015

    Exact Sciences (EXAS) Fails to Impress U.S. Preventative Task Force (USPTF), EXAS Shares should Slide...

    mtsDNA (Stool DNA Plus FIT)



    The mtsDNA test (Cologuard®), concurrently approved by the FDA for marketing and by CMS for coverage in August 2014, combines the results of a FIT and DNA marker assays. It is the most expensive of stool tests, reimbursed by CMS at $493 per test.307 In comparison, the cost of FITs is generally much lower, with a CMS reimbursement of $23 and a mean commercial reimbursement of $21 per test.308 In one large study (n=9989), mtsDNA was statistically significantly more sensitive for CRC at 92.3 percent than OC FIT-CHEK (73.8 percent) using a recommended single stool sample for each test. In other included FIT studies, OC FIT-CHEK had higher estimated sensitivity than observed in this study, when multiple samples or lower assay cutoff was used. However, comparison of test performances across studies is difficult due to differences in study design and population characteristics. In all cases, increasing sensitivity was accompanied by decreasing specificity. Specificity for the mtsDNA test (84.4 percent), for example, was lower than all FIT assays, resulting in the highest false positive rate

    The high rate of unsatisfactory samples for the mtsDNA test (6.25 percent) was concerning when compared to these rates for FITs (0.3 percent). Excluded samples in this study were in part due to leakage in shipping, which the manufacturer reported has since been fixed, as well as a study quality control measure that authors indicate would not be encountered in clinical practice.166 At a programmatic level, information is lacking on patient adherence and the appropriate screening interval, as well as the impact of false positives as a result of lowered specificity.

    POTC~