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congratulations buddy
watching $DDMG
$DYNV impressive run-up...
true that... anyways, nice to see Dr. Jones's team in action...
something around $700K... impressive
Sunshine Heart Submits Investigational Device Exemption to FDA for C-Pulse(R) System Pivotal Trial
Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) announced today that it has filed its submission for an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA).
The Company's IDE submission relates to the proposed use of the C-Pulse Heart Assist System for patients suffering with moderate to severe heart failure. If successful, the Company believes this trial should provide the data required by the FDA to permit approval, which would allow the Company to commercialize the C-Pulse System in the U.S. This pivotal trial follows the FDA's review of the six month safety and efficacy data reported from the 20-patient North America feasibility study. In March, 2012, the FDA completed its review of the C-Pulse System feasibility trial data and concluded that applicable requirements had been met for the Company to move forward with an IDE application for its pivotal trial. Dr. Bill Abraham of Ohio State University Medical Center will be the national principal investigator for this proposed 388 patient pivotal trial. The proposed primary endpoint is reduction of events such as re-hospitalization due to worsening heart failure and heart failure-related mortality. The study will evaluate results for patients that receive the C-Pulse System in comparison to a control group that is managed on optimal medical therapy.
India > matter of the bureaucracy... as I heard they went through bunch of tests (those government peeps tried detector by themselves)... now it is open gate 'cause of approval...
Implant Sciences Joins The International Air Cargo Association
WILMINGTON, MA--(Marketwire - Aug 30, 2012) - Implant Sciences Corporation (OTCQB: IMSC) (PINKSHEETS: IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, today announced it has become a member of The International Air Cargo Association (TIACA), a worldwide organization which advances the interests of air cargo and promotes the industry's role as a vital enabler of world trade and a driver of global economic development. TIACA represents all segments of the air cargo logistics industry. Its unique membership makes it the perfect platform for companies to network, address industry issues and share knowledge. Members include some of the largest airlines, freight forwarders, shippers, and airports in the world.
"Implant Sciences has been seeing growing interest from the air cargo logistics community. Our QS-H150 product is currently used for cargo screening in Europe and Asia, and our QS-B220 is moving through the air cargo screening certification process in the United States," stated Glenn Bolduc, Implant Sciences' President and CEO. "We look forward to working with TIACA and its member companies to further the interests of the air cargo industry."
http://www.marketwire.com/press-release/implant-sciences-joins-the-international-air-cargo-association-otcqb-imsc-1696238.htm
trying to guess who's behind of this one...
impressive volume 2day...
http://newyork.cbslocal.com/personality/mike-xirinachs/
cannot find contacts so far...
$SRSR > $.10 sooooooon
FDA Lifts Clinical Hold on Lpath's iSONEP
Lpath, Inc. (OTCQB: LPTN), the industry leader in bioactive lipid-targeted therapeutics, reported that the FDA has lifted the clinical hold on iSONEP™, Lpath's anti-S1P monoclonal antibody that is being developed as a potential treatment for wet AMD and possibly other ocular disorders.
The hold was placed on iSONEP in late January 2012 after the FDA deemed that the company's fill/finish contractor was not in compliance with the FDA's Good Manufacturing Practice (cGMP) requirements for approximately a three-year period (2008-2010) -- and it was during this period that the previous iSONEP clinical vials were filled.
iSONEP was well tolerated by all patients in the Phase 1 trial, as well as by all patients treated in the PEDigree and Nexus studies before dosing was suspended in January. The company has not received any claims raising safety concerns with iSONEP.
Lpath has since manufactured new clinical material, utilizing a different fill/finish supplier. The manufacturing process and new drug supply met all specifications, leading to the FDA's action to allow the Nexus trial to continue.
Lpath's Nexus study is now open for enrollment, with plans to treat the first patient in mid-September.
Nexus is a Phase 2 double-blind, multi-site trial in which Lpath plans to dose 160 subjects that have not responded completely to a VEGF inhibitor (either Lucentis® or Avastin®). These subjects will be randomized into four arms: (1) VEGF inhibitor alone; (2) combination of a VEGF inhibitor and iSONEP (lower dose); (3) combination of a VEGF inhibitor and iSONEP (higher dose); and (4) iSONEP alone (higher dose).
Endpoints to be studied include change in best corrected visual acuity (BCVA), change in retinal thickness, and change in lesion size. The Nexus trial will also look at iSONEP's ability to flatten Pigmented Epithelial Detachments (PEDs), a complication that is secondary to wet AMD and one that does not respond well to anti-VEGF treatments. Given this, the PEDigree Phase 1b study, which focused primarily on iSONEP's ability to treat PEDs, has been de-prioritized.
In Lpath's Phase 1 trial, where subjects with wet AMD received a single injection of iSONEP, a positive biological effect was observed in most patients, almost all of whom had failed to respond to treatment with Lucentis and/or Avastin. One such positive effect was a significant reduction (30%+) in the size of the choroidal neovascular lesion in many of the subjects, all of whom were not responding well to treatment with the VEGF inhibitors at the time they were enrolled in the study. Significant reduction in lesion size with a single injection is not typically observed with VEGF inhibition.
One of these subjects experienced a 100% reduction in lesion size as of Day 45. This subject did not have to be re-injected with the "standard of care" (i.e., with Lucentis or Avastin) for the entire twelve-month monitoring period following the iSONEP injection.
Another subject, who had undergone 16 prior treatments of Lucentis and Avastin without much response, was administered the highest dose of iSONEP studied (1.8 mg.). This subject experienced not only a 100% reduction in lesion size by Day 15, but also a complete elimination of retinal swelling. Like the other subject, this subject also did not have to be re-injected with Lucentis or Avastin for the entire 12-month monitoring period following the iSONEP treatment.
These extended times to re-treatment suggest that any benefit derived from iSONEP may be durable, a particularly important attribute in this market.
Lpath hypothesizes that such distinctive benefits are due to powerful anti-angiogenic, anti-inflammatory, and anti-fibrotic mechanisms of action of iSONEP, which binds to and neutralizes the bioactive lipid, S1P. In various animal models of disease, iSONEP was shown to substantially reduce inflammation and angiogenesis in the eye (Campochiaro et al., Journal of Cellular Physiology, January 2009) and significantly mitigate ocular fibrosis (Grant et al., Experimental Eye Research, March 2009).
"Although the VEGF inhibitors have raised the bar considerably in the treatment of wet AMD, there is significant room for improvement," noted Glenn Stoller, M.D., head of Lpath's ocular division. "The VEGF inhibitors treat retinal edema and vascular leakage, but they do little to eliminate or even reduce the lesion themselves, resulting in treatments that must be administered monthly or bi-monthly for life. We are hopeful the reduction of lesion size we saw in the iSONEP Phase 1 trial will be repeated in larger groups of patients, like in this Nexus trial."
Scott Pancoast, Lpath's president and chief executive officer, added: "We are pleased to be open for enrollment and look forward to continuing the Nexus trial. We continue to have high hopes for iSONEP and believe that the Nexus study will help determine how iSONEP can best be used to benefit wet-AMD patients. Whether as first-line single agent, as first-line in combination with anti-VEGF therapies, or as second-line, the market potential for a drug that can provide additive benefits in wet AMD is substantial."
Lpath to Present at the 2012 Gateway Conference on September 6
Lpath, Inc. (OTCQB: LPTN), the industry leader in lipidomics-based therapeutics, has been invited to present at the 2012 Gateway Conference being held on September 6 at the W San Francisco Hotel.
Lpath management is scheduled to present at 11:30 a.m. Pacific time, with one-on-one meetings held throughout the day.
Management will discuss its pathway to regulatory approval and commercialization of its novel lipidomics-based therapeutics, including the imminent resumption of Nexus, a Phase 2 trial where, in partnership with Pfizer, Lpath's anti-S1P antibody iSONEP is being studied in wet-AMD patients.
yeap, press the button http://investorshub.advfn.com/boards/profilea.aspx?user=342458
lol
$GKNI > volume from nowhere...
still restricted for tradin' in Ontario for over a year... they should do somethin' 'bout it...
http://www.prweb.com/releases/2012/8/prweb9827291.htm
geez, this promo takes awhile... lol
it needs a bit more time
those boys were right. lol
http://pennystockhaven.com/aps-enthusiasts-what-the-f-are-you-doing/
$VLNX > this crap should trade the entire OS in an hour. lol
vlnx > MICA, WDCO > usual APS crappy style
vlnx - float traded
guess so...
vlnx > new scam play?
8-K came today http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=8423592
Patriot Minefinders Inc. (OTCBB:PROF) ("Patriot") is pleased to announce it is arranging a financing consisting of the issuance of 2 million common shares at a price of $0.25 per share for total gross proceeds of $500,000. Proceeds of the financing will be used to fund the company’s work commitment at the La Buena Project located in Zacatecas, Mexico and for general working capital.
La Buena is only 5.6 miles from Goldcorp’s world class Penasquito Mine.Penasquito, owned and operated by Goldcorp Inc., will be Mexico's largest open pit mine and is host to the world-class gold-silver-lead-zinc Penasquito deposit. Patriot's upcoming exploration work at La Buena will focus on geologically similar areas, particularly an area of La Buena called the Julia Zone which hosts a large, drill ready coincident geophysical and geochemical anomaly with similarities in underlying geology to Penasquito.
With the focus on the La Buena Project, Patriot has assembled a world class Board of Directors who possess international exploration, development and production experience around the world.
Patriot's joint venture and operating partner at La Buena has developed a number of high priority targets on the property including the drill ready Julia Zone and the highly prospective San Lucas Ridge Zone. Upcoming work being planned La Buena includes the drilling of the Julia Zone to test recently identified coincident geophysical and geochemical targets in a geological setting similar to Penasquito, along with ground geophysics and geochemical work in the San Lucas Ridge Zone and in other areas of the large 8500 hectare (21,000 acre) land package.
On behalf of management,
John Schweitzer, Chief Executive Officer
200K shares sold from Dec 2011 to April 4th, 2012 (last sale was almost 6month back)
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=8770330
Yahoo MB is full of sh*t
CEO mentioned this date
9 trading days 'till approval...
should not deep further... next sales numbers or/and partnerships may send it back to over $9... just watching when the dust settles
week of August 26th...
man, that's a patience to freeze over 60K for a month...
kinda confused, LBI Group sold 2,187,918 shares from its 1,447,293 holdings?