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GTHP

Guided Therapeutics

09:25
07/18/17
07/18
09:25
07/18/17
09:25

Guided Therapeutics reopens communications with FDA for LuViva

Guided Therapeutics announced that it has re-opened discussions with the U.S. Food and Drug Administration regarding U.S. premarket approval of the Company's LuViva Advanced Cervical Scan. The company's decision was prompted by a constructive outcome from the company's previous face-to-face meeting with FDA and a perceived more favorable environment for device approvals under the new presidential administration, along with a recent increase in device approvals at the FDA. In connection with the company's plan to re-file for approval of its LuViva Advanced Cervical Scan, it plans on conducting a new clinical study to confirm previous results already submitted to the FDA. In a telephonic meeting with the FDA, the company discussed initiating the process by submitting a new study protocol and discussed the possibility of submitting the study data under FDA's 510(k) de Novo regulations, which, if accepted, could potentially speed up the approval process. The new clinical study is expected take approximately nine months to complete, after which the company would submit the data to the FDA. The company intends on initiating the process by submitting the new study protocol to the FDA within 30 days after funding has been secured. Once final clinical study data has been submitted to the FDA, the FDA will have 180 days to respond with a decision or additional questions.

TODAY'S FREE FLY STORIES

GRMN

Garmin

$51.66

1.45 (2.89%)

10:34
07/20/17
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10:34
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Garmin acquires privately held Alphamantis Technologies; terms not disclosed »

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BG

Bunge

$77.16

-1.5283 (-1.94%)

10:33
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Bunge sees Q2 adjusted net income below low end of range of estimates »

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10:30
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General news
EIA natural gas storage change for week ending July 14 »

Gas inventories 28 Bcf…

CHRW

C.H. Robinson

$68.69

-0.81 (-1.17%)

10:30
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Options
Put buyers in CH Robinson as shares fall on earnings »

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General news
Today's U.S. reports »

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STLD

Steel Dynamics

$37.49

0.99 (2.71%)

10:29
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Breaking Hot Stocks news story on Steel Dynamics »

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XOM

Exxon Mobil

$81.30

0.45 (0.56%)

10:29
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Periodicals
Exxon Mobil fined $2M over Ukraine-related sanctions violations, Reuters says »

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HD

Home Depot

$146.69

-6.615 (-4.32%)

, LOW

Lowe's

$73.43

-3.4 (-4.43%)

10:27
07/20/17
07/20
10:27
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10:27
Recommendations
Home Depot, Lowe's analyst commentary  »

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HD

Home Depot

$146.69

-6.615 (-4.32%)

LOW

Lowe's

$73.43

-3.4 (-4.43%)

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STLD

Steel Dynamics

$37.49

0.99 (2.71%)

, NUE

Nucor

$58.99

-1.67 (-2.75%)

10:27
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Hot Stocks
Steel Dynamics CEO says flat rolled enviroment steady despite auto »

Industry will follow…

STLD

Steel Dynamics

$37.49

0.99 (2.71%)

NUE

Nucor

$58.99

-1.67 (-2.75%)

X

U.S. Steel

$24.08

-0.39 (-1.59%)

AKS

AK Steel

$6.52

-0.08 (-1.21%)

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PFE

Pfizer

$33.60

-0.025 (-0.07%)

, MRK

Merck

$63.18

0.555 (0.89%)

10:26
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Hot Stocks
Credit Suisse cuts Pfizer to hold, prefers Merck, J&J »

Credit Suisse downgraded…

PFE

Pfizer

$33.60

-0.025 (-0.07%)

MRK

Merck

$63.18

0.555 (0.89%)

JNJ

Johnson & Johnson

$136.04

0.83 (0.61%)

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10:25
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General news
U.S. leading economic index rose 0.6% to 127.8 in June »

U.S. leading economic…

C

Citi

$66.79

0.09 (0.13%)

10:25
07/20/17
07/20
10:25
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10:25
Conference/Events
Citigroup to hold a conference call »

CFO Gerspach holds a…

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STLD

Steel Dynamics

$37.49

0.99 (2.71%)

10:21
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Hot Stocks
Breaking Hot Stocks news story on Steel Dynamics »

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  • 20

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TSLA

Tesla

$325.26

-2.98 (-0.91%)

10:21
07/20/17
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Hot Stocks
Citi awaits better Tesla entry point as bulls, bears both make good points »

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VRTX

Vertex

$159.69

27.53 (20.83%)

10:20
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10:20
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Options
Large call spread in Vertex Pharm after yesterday's surge »

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  • 26

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10:20
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General news
Treasury Action: longer yields rotated lower again »

Treasury Action: longer…

STLD

Steel Dynamics

$37.49

0.99 (2.71%)

10:19
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Breaking Hot Stocks news story on Steel Dynamics »

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TSLA

Tesla

$325.26

-2.98 (-0.91%)

, JNJ

Johnson & Johnson

$136.03

0.82 (0.61%)

10:19
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On The Fly: Top five analyst initiations »

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TSLA

Tesla

$325.26

-2.98 (-0.91%)

JNJ

Johnson & Johnson

$136.03

0.82 (0.61%)

TTS

Tile Shop

$14.83

-0.175 (-1.17%)

SBPH

Spring Bank Pharmaceuticals

$14.20

-0.12 (-0.84%)

DISCA

Discovery

$27.18

1.13 (4.34%)

SNI

Scripps Networks

$76.89

9.87 (14.73%)

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PFE

Pfizer

, RAD

Rite Aid

$2.50

-0.1322 (-5.03%)

10:19
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Downgrade
On The Fly: Top five analyst downgrades »

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PFE

Pfizer

RAD

Rite Aid

$2.50

-0.1322 (-5.03%)

FMSA

Fairmount Santrol

$3.63

-0.245 (-6.33%)

NEWR

New Relic

$47.96

-0.84 (-1.72%)

SND

Smart Sand

$7.87

0.25 (3.28%)

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NKE

Nike

$59.31

1.54 (2.67%)

, BGS

B&G Foods

$37.08

1.275 (3.56%)

10:18
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Upgrade
On The Fly: Top five analyst upgrades »

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NKE

Nike

$59.31

1.54 (2.67%)

BGS

B&G Foods

$37.08

1.275 (3.56%)

HPQ

HP Inc.

$18.86

0.155 (0.83%)

RCL

Royal Caribbean

$115.14

2.5775 (2.29%)

BWLD

Buffalo Wild Wings

$122.60

0.65 (0.53%)

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  • 26

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STLD

Steel Dynamics

$37.49

0.99 (2.71%)

10:18
07/20/17
07/20
10:18
07/20/17
10:18
Hot Stocks
Steel Dynamics sees more stabilized scrap environment in 2H »

Comments from Q2 earnings…

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  • 20

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$NSD

NASDAQ Market Internals

10:17
07/20/17
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10:17
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NASDAQ market internals summary »

Volume is average for…

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$NYE

NYSE Market Internals

10:16
07/20/17
07/20
10:16
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10:16
Technical Analysis
NYSE market internals summary »

Volume is below average…

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10:15
07/20/17
07/20
10:15
07/20/17
10:15
General news
FX Action: The dollar »

FX Action: The dollar…

10:15
07/20/17
07/20
10:15
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General news
Breaking General news story  »

Week of 7/14 EIA Natural…

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