The 2016 European Nations CUP (soccer - football).

[BertOMahon]

I had in mind to open a soccer thread has we have 2 important competitions
The America Nation Cup and European Nation cups
but as no one talking about it I presume no many here like-follow the soccer (football for us EU)

I give the America's link to follow the competition

[BurtonKr]

"Currently, there is no approved treatment for patients in septic shock, the most advanced and lethal stage of sepsis, and clinicians are left with very few options to treat the sickest of patients," said Dr. Paul Walker, President and CEO of Spectral. "Toraymyxin? represents a new solution for sepsis treatment and has been used on more than 150,000 patients outside of North America over the course of more than a decade. Provided the FDA approves our Expanded Access program, this treatment could be available soon for use in select patients at participating clinical trial locations in the United States."

Spectral also provided guidance today on several significant clinical and regulatory milestones:

As of today, only four patients remain to be enrolled in the EUPHRATES trial, which is fully on track to be completed by no later than June 30, 2016.

The FDA has accepted Spectral's statistical analysis plan for the PMA submission of Toraymyxin?. Subsequent to analysis of the trial data, the Company expects to announce primary end point results around the end of September 2016 and will then submit the last module of the PMA. The first three modules have already been submitted to the FDA. Assuming positive clinical data and barring any unexpected delays, Spectral anticipates a decision from the FDA as early as the first quarter of 2017.

[bygjreib80]

In anticipation of potential FDA approval of Toraymyxin?, Spectral and Toray Industries Inc. (Toray) are both taking the necessary operational steps to scale up manufacturing capabilities in order to be ready to begin sales in the first half of 2017. A new plant has been built by Toray in Japan for the manufacture of Toraymyxin? and EAA? manufacturing capacity has been expanded in Toronto. The Company is also currently engaged in confidential discussions with potential interested partners that have existing sales and marketing infrastructures and it will be evaluating all potential options going forward.
"The progress we have demonstrated so far represents the culmination of six years of diligent work on clinical, regulatory and commercialization programs to bring the first approved product for endotoxemic septic shock to market and the finish line is in sight," added Dr. Paul Walker. "The imminent completion of patient enrollment in the EUPHRATES trial is an important step that brings Spectral significantly closer to addressing an enormous unmet medical need."

[Catgess]

Company remains on track and anticipates final submission in Q4 2016

FDA accepts Spectral's 510(k) filing for its standalone pump for review


TORONTO, ONTARIO--(Marketwired - June 16, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT) (OTCQX:EDTXF), a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today announced that the U.S. Food and Drug Administration (FDA) has reviewed and accepted one of the two pre-clinical modules in its PMA application for Toraymyxin?, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. With acceptance of this module the Company remains on track to complete its full PMA submission by the end of 2016.
"As we look toward completing our submission to the FDA this year, the Agency's acceptance of this module is a significant milestone," said Dr. Paul Walker, President and CEO of Spectral. "This particular section contains key pre-clinical data on the use of Toraymyxin? for patients with septic shock, including the device's engineering and bench testing; sterilization and shelf life; packaging and transport details. We are encouraged that the FDA accepted this data, which is critical to our submission, as we continue to advance our regulatory filing with the goal of bringing this treatment to people in need."

[admin]

A novel therapy for certain patients in septic shock, Toraymyxin™ is specifically targeted at those with elevated levels of endotoxin in the blood. Toraymyxin™ is a direct hemoperfusion adsorption column that has been shown to be highly effective in removing endotoxin. Studies have shown that this medical device can remove up to 90 percent of an endotoxemic patient's circulating endotoxin when administered twice within a 24 hour period.
As part of the modular PMA filing, Spectral will submit a total of four modules of documentation for review in stages by the FDA. Two of the modules include pre- clinical information, one describes the manufacturing process and the last module contains clinical data. Three modules have been submitted and one of the pre- clinical modules has now been fully reviewed and accepted. Spectral plans to submit its fourth and final module, comprising data from its pivotal EUPHRATES trial, by the end of 2016.
In related news, Spectral announced that the FDA has also accepted for review the Company's separate 510(k) filing for a standalone pump that could facilitate treatment delivery in the Intensive Care Unit (ICU) and increase options available to clinicians.