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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

HPE

HP Enterprise

$14.70

0.09 (0.62%)

19:12
10/18/17
10/18
19:12
10/18/17
19:12
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HP Enterprise raises share buyback by $5B, raises regular dividend 15% »

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HPE

HP Enterprise

$14.70

0.09 (0.62%)

19:11
10/18/17
10/18
19:11
10/18/17
19:11
Hot Stocks
HPE to simplify organizational structure, to drive cost savings of $1.5B »

HPE President Antonio…

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HPE

HP Enterprise

$14.70

0.09 (0.62%)

19:10
10/18/17
10/18
19:10
10/18/17
19:10
Earnings
HP Enterprise sees FY17 adjusted EPS view roughly $1.00, consensus $1.40 »

Sees FY17 revenue growth…

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    Dec

HPE

HP Enterprise

$14.70

0.09 (0.62%)

19:08
10/18/17
10/18
19:08
10/18/17
19:08
Earnings
HP Enterprise sees FY18 adjusted EPS $1.15-$1.25, consensus $1.20 »

HPE expects its non-GAAP…

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CME

CME Group

$136.37

0.18 (0.13%)

19:01
10/18/17
10/18
19:01
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19:01
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CME Group, JPX enter agremenet to launch TOPIX futures contract on CME »

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UAL

United Continental

$67.99

0.48 (0.71%)

18:50
10/18/17
10/18
18:50
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18:50
Hot Stocks
Breaking Hot Stocks news story on United Continental »

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  • 19

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CSX

CSX

$53.68

-0.55 (-1.01%)

18:49
10/18/17
10/18
18:49
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18:49
Hot Stocks
CSX discloses reduction of locomotives in maintenance program »

According to a regulatory…

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VZ

Verizon

$48.65

0.25 (0.52%)

18:41
10/18/17
10/18
18:41
10/18/17
18:41
Periodicals
Verizon targets spring 2018 start of delayed online TV service, Bloomberg says »

Verizon is targeting a…

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  • 19

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IBM

IBM

$159.53

12.99 (8.86%)

18:37
10/18/17
10/18
18:37
10/18/17
18:37
Hot Stocks
IBM CFO: Great start to 2H17 »

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  • 22

    Oct

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SEAS

SeaWorld

$12.31

-0.17 (-1.36%)

18:26
10/18/17
10/18
18:26
10/18/17
18:26
Hot Stocks
SeaWorld to eliminate approximately 350 positions in restructuring program »

On October 18, SeaWorld…

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  • 07

    Nov

JPM

JPMorgan

$97.99

0.37 (0.38%)

18:12
10/18/17
10/18
18:12
10/18/17
18:12
Hot Stocks
SEC names JPMorgan exec Redfearn Director of Division of Trading and Markets »

The Securities and…

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    Nov

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    Feb

  • 13

    Apr

  • 14

    Jul

  • 12

    Oct

VZ

Verizon

$48.65

0.25 (0.52%)

18:10
10/18/17
10/18
18:10
10/18/17
18:10
Periodicals
Verizon targets spring start of delayed online TV service, Bloomberg says »

Verizon web TV…

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  • 19

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STLD

Steel Dynamics

$36.44

0.27 (0.75%)

18:04
10/18/17
10/18
18:04
10/18/17
18:04
Hot Stocks
Steel Dynamics CEO optimistic conditions in place to benefit FY18 consumption »

CEO Mark Millet said:…

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  • 19

    Oct

CE

Celanese

$104.03

-0.24 (-0.23%)

18:03
10/18/17
10/18
18:03
10/18/17
18:03
Earnings
Celanese increases price for acetyls and engineered materials products »

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STLD

Steel Dynamics

$36.44

0.27 (0.75%)

18:01
10/18/17
10/18
18:01
10/18/17
18:01
Earnings
Steel Dynamics reports Q3 ex-items EPS 66c, consensus 66c »

Reports Q3 revenue $2.4B,…

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  • 19

    Oct

OPTT

Ocean Power

$2.00

0.56 (38.89%)

17:59
10/18/17
10/18
17:59
10/18/17
17:59
Syndicate
Ocean Power files to sell common stock in 'best efforts' offering »

No amount was provided.…

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  • 20

    Oct

TOSBF

Toshiba, also use TOSYY

$3.02

-0.03 (-0.98%)

, TOSYY

Toshiba, also use TOSBF

$18.20

-0.11 (-0.60%)

17:58
10/18/17
10/18
17:58
10/18/17
17:58
Periodicals
Japan regulators probing Toshiba reporting practices for FY16/17, Nikkei says »

Japan's Securities…

TOSBF

Toshiba, also use TOSYY

$3.02

-0.03 (-0.98%)

TOSYY

Toshiba, also use TOSBF

$18.20

-0.11 (-0.60%)

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PNW

Pinnacle West

$87.34

-0.42 (-0.48%)

17:53
10/18/17
10/18
17:53
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17:53
Hot Stocks
Pinnacle West raises quarterly divided 6.1% to 69.5c per share »

Pinnacle West…

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GILD

Gilead

$80.01

-0.23 (-0.29%)

17:46
10/18/17
10/18
17:46
10/18/17
17:46
Hot Stocks
FDA grants regulatory approval to Kite's Yescarta »

Kite, a Gilead company,…

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POT

Potash

$19.24

0.08 (0.42%)

, AGU

Agrium

$107.73

0.55 (0.51%)

17:37
10/18/17
10/18
17:37
10/18/17
17:37
Hot Stocks
Potash, Agrium: India approves proposed merger of equals transaction »

Potash Corporation of…

POT

Potash

$19.24

0.08 (0.42%)

AGU

Agrium

$107.73

0.55 (0.51%)

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VMI

Valmont

$160.85

1.9 (1.20%)

17:36
10/18/17
10/18
17:36
10/18/17
17:36
Earnings
Valmont lowers FY17 adjusted EPS view to $6.90-$7.04 from $7.06, consensus $7.09 »

Annual guidance was…

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  • 19

    Oct

NVO

Novo Nordisk

$50.13

0.82 (1.66%)

17:36
10/18/17
10/18
17:36
10/18/17
17:36
Hot Stocks
Novo Nordisk receives positive 16-0 vote from FDA Advisory Committe »

Novo Nordisk announced…

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  • 18

    Oct

CHFS

CHF Solutions

$8.30

-0.69 (-7.68%)

17:35
10/18/17
10/18
17:35
10/18/17
17:35
Syndicate
Breaking Syndicate news story on CHF Solutions »

CHF Solutions files to…

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  • 06

    Nov

VTGN

VistaGen Therapeutics

$1.31

0.04 (3.15%)

17:33
10/18/17
10/18
17:33
10/18/17
17:33
Syndicate
Breaking Syndicate news story on VistaGen Therapeutics »

VistaGen Therapeutics…

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LLNW

Limelight Networks

$4.48

0.12 (2.75%)

, URI

United Rentals

$144.32

0.98 (0.68%)

17:32
10/18/17
10/18
17:32
10/18/17
17:32
Hot Stocks
On The Fly: After Hours Movers »

UP AFTER EARNINGS:…

LLNW

Limelight Networks

$4.48

0.12 (2.75%)

URI

United Rentals

$144.32

0.98 (0.68%)

KMI

Kinder Morgan

$18.58

-0.1 (-0.54%)

ADBE

Adobe

$153.00

2.62 (1.74%)

CNAT

Conatus

$5.15

0.05 (0.98%)

EBAY

eBay

$37.97

0.48 (1.28%)

HXL

Hexcel

$58.94

0.39 (0.67%)

CCI

Crown Castle

$100.96

-0.42 (-0.41%)

ESTE

Earthstone Energy

$10.54

-0.15 (-1.40%)

PEGI

Pattern Energy

RXDX

Ignyta

$16.25

1.9 (13.24%)

HCA

HCA Healthcare

$77.45

0.63 (0.82%)

KLAC

KLA-Tencor

$108.09

0.08 (0.07%)

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