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ADMD SOLID PLAY BOUNCE COMING
STRONG HANDS IN WAHOOO ADMD BOUNCE COMING
THIS IS ABOUT TO BLOW PAST THESE LEVELS JUST WATCH BETTER LOAD UP IMO :) WAIT WAIT LET ME LOAD
FDA RESUBMISSION BIG THINGS COMING NOT THE ONLY THING JUST ONE OF THE MANY
strong in Weak hands out lets move
12's about to get eaten chomp chomp :) ADMD SOLID
IF THIS GETS FDA APPROVED WE WILL SEE PENNIES AND MORE GOLDEN GEM HERE
Advanced Medical Isotope Corporation Files a "de novo" Submission for Y-90 RadioGel(TM) Device PR Newswire "Press Releases US - English"
KENNEWICK, Wash. , Dec. 23, 2014 /PRNewswire/ --Advanced Medical Isotope Corporation ("AMIC") (OTCQB:ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that it has filed a de novo submission with the Food and Drug Administration (" FDA ") for marketing clearance for its patented Y-90 RadioGel(TM) device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act (the "Act").
Major bounce coming ADMD
SOmeone was trying to bring this down in my opinion
I believe we are in for a bounce excellent news out
HUGE MOVE COMING SOLID COMPANY ADMD WITH HUGE NEWS IN THE PIPELINE
EXCELLENT NEWS
ADMD IS SOLID AND SET FOR A REVERSAL
BOUNCE COMING NEW HOD
ADMD HUGE FDA RESUBMISSION NEWS
THIS WILL GO BIG WATCH
SOMEONE WANTS SHARES
FDA RESUBMISSION HUGE NEWS
HUGE MOVE COMING
Advanced Medical Isotope Corporation Files a "de novo" Submission for Y-90 RadioGel(TM) Device PR Newswire "Press Releases US - English"
KENNEWICK, Wash. , Dec. 23, 2014 /PRNewswire/ --Advanced Medical Isotope Corporation ("AMIC") (OTCQB:ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that it has filed a de novo submission with the Food and Drug Administration (" FDA ") for marketing clearance for its patented Y-90 RadioGel(TM) device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act (the "Act").
In February 2014 , the FDA rejected the Company's request for marketing clearance for the same device under Section 510(k) of the Act. The FDA determined that the device was not substantially equivalent, concluding that the device is classified by statute as a Class III medical device, unless the device is reclassified.
By filing the de novo submission, the Company is seeking reclassification of the product to Class II. The FDA has 120 days in which to make a decision, though the period will be extended for any time AMIC requires to respond to FDA requests for additional information. If the de novo submission is granted, the device may be immediately marketed in the United States , though the Company would have to secure funding and commercial arrangements before marketing could commence. If the de novo submission is declined, the Company will explore steps toward seeking approval for the device as a Class III medical device. Generally, the time period and cost of seeking approval as a Class III medical device is materially greater than the time period and cost of seeking approval as a Class II medical device.
The Company's ability to pursue regulatory approvals and ultimately to commercialize this device, or its other products, is dependent upon the Company's securing additional funding. The recent decline in the Company's share price, the FDA's rejection of the Company's request for marketing clearance through the 510(k) process for the Y-90 RadioGel(TM) device, a reduction of the Company's level of activities arising from a lack of funds, the Company's outstanding debt, payables and conversion features of its debt have made it more difficult for the Company to secure capital. Nonetheless, the Company continues its efforts to address the foregoing weaknesses, to seek capital and to reduce its debt and payables.
About Advanced Medical Isotope Corporation Advanced Medical Isotope Corporation (OTCBB: ADMD) is a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications. AMIC's focus is on transitioning to full operations upon receipt of FDA clearance for its patented brachytherapy cancer products. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. Annual sales of brachytherapy products exceed $1 billion , about half of which are in the United States. The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States , though the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our website, www.isotopeworld.com.
Safe Harbor Statement This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, AMIC's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/advanced-medical-isotope-corporation-files-a-de-novo-submission-for-y-90-radiogeltm-device-300013648.html
SOURCE Advanced Medical Isotope Corporation
THE NEWS IS REAL NOW YOU SEE IT NOW YOU SHUSH :)
HUGE MOVE COMING HUGE NEWS
O MY GOD HUGE HUGE HUGEEE NEWS
O MY GOD PENNIES COMING O MY GOD
ADMD READY TO MOVE THIS IS A SOLID STOCK WATCH FOR NEW HOD
ADMD explosion i smell it :)
ADMD MUST READ About Battelle
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. Battelle operates Pacific Northwest National Laboratory in Richland, Wash., for the U.S. Department of Energy. For more information, visit www.battelle.org.
KENNEWICK, Wash., Sept. 16, 2014 /PRNewswire/ -- Advanced Medical Isotope Corporation ("AMIC") (OTCQB: ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that a patent was awarded for technology related to its brachytherapy products. AMIC's rights for the newly issued patent arise from its license from Battelle, under which AMIC exclusively licensed technologies developed at Pacific Northwest National Laboratory and the University of Utah for its proposed brachytherapy products. The patent awarded, US 8,821,364 B2, relates to AMIC's brachytherapy seed product and is entitled: Brachytherapy Seed with Fast Dissolving Matrix for Optimal Delivery of Radionuclides to Cancer Tissue. AMIC will support Battelle in further patent protection for additional markets consistent with AMIC's overall global commercialization strategy.
Brachytherapy is the use of radiation to destroy cancerous tumors by placing a radiation source inside or next to the treatment area. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion.
Subject to receipt of required regulatory approvals from the FDA in the United States and analogous regulators outside of the United States, AMIC plans to introduce an innovative yttrium-90 (Y-90) based brachytherapy product line for a range of applications for the delivery of prescribed doses of radiation to target sites. The initial proposed products consist of:
Y-90 Fast-Resorbable Polymer Seeds - Y-90 contained within a polymer seed, as opposed to metal or glass.
Y-90 RadioGel(TM) device - combines Y-90 particles with a polymer carrier that may be injected directly into the tumor.
Y-90 Polymer Topical Paste – designed to be applied directly to tissue surfaces after surgical tumor removals (also referred to as "resections") to treat residual tumor cells.
Based upon its studies and analyses, AMIC believes that once approved for commercial use by the FDA and other regulators, its brachytherapy products are likely to offer numerous benefits for patients and medical professionals including:
High Therapeutic Index: This implies that more radiation energy may be imparted to target tissues, with less radiation reaching adjacent normal tissues.
Half Life: Y-90 has a half-life of just 2.7 days. Many traditional brachytherapy products use isotopes with longer half-lives such as 9.7 days for cesium-131, and sixty days for iodine-125.
No Permanent Seeds Remaining: Current brachytherapy devices place permanent metal or glass seeds in the tumor. AMIC's Y-90 brachytherapy seed utilizes a biodegradable, non-toxic polymer that is absorbed by the body.
Good Safety Profile: Many traditional brachytherapy devices utilize isotopes that emit x-rays (akin to gamma radiation). X-rays or gamma radiation travels within and outside of the body. AMIC's brachytherapy products use the yttrium-90 isotope, which is a beta-emitter. The yttrium-90 beta-emissions travel only a short distance.
Potential Lower Cost: Yttrium-90 supplies are readily accessible and are relatively inexpensive. The elimination of the metal or glass enclosures used in traditional brachytherapy seeds greatly reduces manufacturing costs.
AMIC CEO and Chairman James C. Katzaroff stated: "We are delighted that the U.S. Patent office has awarded this patent related to our brachytherapy seed product. We believe that there is a strong market for this product and that it offers significant benefits to patients and healthcare providers over existing brachytherapy seed products."
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (OTCBB: ADMD) is a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications. AMIC's focus is on transitioning to full operations upon receipt of FDA clearance for its patented brachytherapy cancer products. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. Annual sales of brachytherapy products exceed $1 billion, about half of which are in the United States. The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our website, www.isotopeworld.com.
About Battelle
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. Battelle operates Pacific Northwest National Laboratory in Richland, Wash., for the U.S. Department of Energy. For more information, visit www.battelle.org.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, AMIC's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
SOURCE Advanced Medical Isotope Corporation
Bounce coming added to my position today as well
THE LAST NEWS READ IT AND BE SURPRISED :)
ADMD ready to move
The Licensed Brachytherapy Seed Grant is a HUGE development for ADMD
Strong hands here to stay :) ADMD
Real buyers who see where this company is headed amen
NOPE JUST WEAK HANDS OUT HAHAHA NOW TIME TO MOVE UP
RECEIVED GRANT AND FUNDING FOR ITS TOP NOTCH MEDICAL CANCER FIGHTING TECHNOLOGY!!!!! WAHOOOOOO
ADMD is highly highly undervalued NEW GRANT RECEIVED THIS WEEK! YOU KNOW WHAT THAT MEANS
LOADING ZONE
People WANT SHARES HERE ADMD$