Showing posts with label Staff. Show all posts
Showing posts with label Staff. Show all posts

Thursday, June 13, 2013

BRIEF-FDA staff does not recommend approval of Abbott's MitraClip

March 18 (Reuters) - Abbott Laboratories :

* FDA staff says approval of Abbott's MitraClip not appropriate at the

time as major questions of safety, efficacy & risks remain unanswered

* FDA staff recommends Abbott's MitraClip to remain available for high risk

patients so Abbott can conduct its trials in an optimal manner

* FDA staff says the analyses included in Abbott's MitraClip marketing

application do not have valid scientific evidence of safety & efficacy

* Source text * Further company coverage ((Bangalore Newsroom; +1 646 223 8780))


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Wednesday, June 12, 2013

UPDATE 1-FDA staff does not recommend approval of Abbott's heart device

(Adds details, Abbott and analyst comments, stock movement)

March 18 (Reuters) - Staff reviewers for the U.S. Food and Drug Administration did not recommend the approval of Abbott Laboratories' implantable heart device MitraClip, citing a lack of "valid scientific evidence" of safety and effectiveness.

FDA reviewers said in briefing documents, posted on the regulator's website on Monday, that approval of the device would not be appropriate at the time as major questions of safety, efficacy and overall benefit-risk profile remained unanswered.

The device is being tested to treat mitral valve insufficiency - a disorder where a heart valve does not close properly when the heart pumps blood, causing blood to flow back into the heart - in patients considered high risk for open surgery.

The device is inserted into the blood stream using a catheter.

"The FDA staff is asking for more information. Abbott is conducting multiple trials on MitraClip, including the COAPT study, and the staff would want to look at that data," BMO Capital Markets analyst Joanne Wuensch said.

The COAPT trial is testing the device in high-risk inoperable and high-risk mitral valve patients. Abbott has also recently developed a European trial for the patient population.

Abbott had changed the proposed use for the device after the FDA expressed concerns that there was a lack of evidence to support its approval for a broader use in patients with significant mitral valve insufficiency, the reviewers said in the documents. ()

"FDA firmly believes that the currently enrolling COAPT and European trials are well-designed trials that will help to answer the many important questions posed by the very limited data analyses presented in this (approval application)," the reviewers said.

However, the reviewers recommended that MitraClip continue to remain available to high-risk patients as an investigational device so that Abbott can conduct its trials in an optimal manner.

"The MitraClip device represents a true advance for (high-risk) patients and we look forward to discussing the totality of the clinical evidence with the advisory committee members and hearing their recommendations on Wednesday," Abbott said in an emailed statement to Reuters.

An advisory panel of independent experts will discuss the data submitted by Abbott on the device and will vote on its safety, efficacy and risk profile.

BMO's Wuensch said her earnings estimate on Abbott did not include any expected revenue from MitraClip, adding that she believed the Street consensus also excluded any potential sales from the device.

Abbott shares were down 1.2 percent at $33.72 on the New York Stock Exchange on Monday.

(Reporting by Esha Dey in Bangalore; Editing by Maju Samuel and Roshni Menon)

((esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net))

Keywords: ABBOTT FDA/MITRALVALVEDEVICE


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Sunday, March 31, 2013

Remarks by the President in Presentation of the Medal of Honor to Staff Sergeant Clinton L. Romesha

The White House

Office of the Press Secretary

East Room

1:40 P.M. EST

THE PRESIDENT:  Good afternoon.  And on behalf of Michelle and myself, welcome to the White House.

Every day at the White House we receive thousands of letters from folks all across America.  And at night, upstairs in my study, I read a few.  About three years ago, I received a letter from a mom in West Virginia.  Her son, Stephan, a Specialist in the Army, just 21 years old, had given his life in Afghanistan.  She had received the condolence letter that I’d sent to her family, as I send to every family of the fallen.  And she wrote me back.  “Mr. President,” she said, “you wrote me a letter telling me that my son was a hero.  I just wanted you to know what kind of hero he was.”

“My son was a great soldier,” she wrote.  “As far back as I can remember, Stephan wanted to serve his country.”  She spoke of how he “loved his brothers in B Troop.”  How he “would do anything for them.”  And of the brave actions that would cost Stephan his life, she wrote, “His sacrifice was driven by pure love.”

Today, we are honored to be joined by Stephan’s mother Vanessa and his father Larry.  Please stand, Vanessa and Larry. (Applause.)  We're joined by the families of the seven other patriots who also gave their lives that day.  Can we please have them stand so we can acknowledge them as well.  (Applause.)  We're joined by members of Bravo Troop whose courage that day was driven by pure love.  And we gather to present the Medal of Honor to one of these soldiers -- Staff Sergeant Clinton L. Romesha.

Clint, this is our nation’s highest military decoration.  It reflects the gratitude of our entire country.  So we’re joined by members of Congress; leaders from across our Armed Forces, including Secretary of Defense Leon Panetta, Chairman of the Joint Chiefs of Staff Marty Dempsey, Army Secretary John McHugh, and Army Chief of Staff General Ray Odierno.  We are especially honored to be joined by Clint’s 4th Infantry Division -- “Iron Horse” -- soldiers, and members of the Medal of Honor Society, who today welcome you into their ranks.

Now, despite all this attention, you may already have a sense that Clint is a pretty humble guy.  We just spent some time together in the Oval Office.  He grew up in Lake City, California -- population less than a hundred.  We welcome his family, including mom and dad, Tish and Gary.  Clint -- I hope he doesn’t mind if I share that Clint was actually born at home. These days, Clint works in the oilfields of North Dakota.  He is a man of faith, and after more than a decade in uniform, he says the thing he looks forward to the most is just being a husband and a father. 

In fact, this is not even the biggest event for Clint this week, because tomorrow, he and his wife Tammy will celebrate their 13th wedding anniversary.  Clint and Tammy, this is probably not the kind of intimate anniversary you planned.  (Laughter.)  But we’re so glad that you’re here, along with your three beautiful children -- Dessi, Gwen and Colin.  Colin is not as shy as Clint.  (Laughter.)  He was in the Oval Office, and he was racing around pretty good.  (Laughter.)  And sampled a number of the apples before he found the one that was just right.  (Laughter.)  

Now, to truly understand the extraordinary actions for which Clint is being honored, you need to understand the almost unbelievable conditions under which he and B Troop served.  This was a time, in 2009, when many of our troops still served in small, rugged outposts, even as our commanders were shifting their focus to larger towns and cities.

So Combat Outpost Keating was a collection of buildings of concrete and plywood with trenches and sandbags.  Of all the outposts in Afghanistan, Keating was among the most remote.  It sat at the bottom of a steep valley, surrounded by mountains -- terrain that a later investigation said gave “ideal” cover for insurgents to attack.  COP Keating, the investigation found, was “tactically indefensible.”  But that’s what these soldiers were asked to do -- defend the indefensible.

The attack came in the morning, just as the sun rose.  Some of our guys were standing guard; most, like Clint, were still sleeping.  The explosions shook them out of their beds and sent them rushing for their weapons.  And soon, the awful odds became clear:  These 53 Americans were surrounded by more than 300 Taliban fighters. 

What happened next has been described as one of the most intense battles of the entire war in Afghanistan.  The attackers had the advantage -- the high ground, the mountains above.  And they were unleashing everything they had -- rocket-propelled grenades, heavy machine guns, mortars; snipers taking aim.  To those Americans down below, the fire was coming in from every single direction.  They’d never seen anything like it. 

With gunfire impacting all around him, Clint raced to one of the barracks and grabbed a machine gun.  He took aim at one of the enemy machine teams and took it out.  A rocket-propelled grenade exploded, sending shrapnel into his hip, his arm, and his neck.  But he kept fighting, disregarding his own wounds, and tending to an injured comrade instead.

Then, over the radio, came words no soldier ever wants to hear -- “enemy in the wire.”  The Taliban had penetrated the camp.  They were taking over buildings.  The combat was close; at times, as close as 10 feet.  When Clint took aim at three of them, they never took another step.

But still, the enemy advanced.  So the Americans pulled back, to buildings that were easier to defend, to make one last stand.  One of them was later compared to the Alamo -- one of them later compared it to the Alamo.  Keating, it seemed, was going to be overrun.  And that’s when Clint Romesha decided to retake that camp.

Clint gathered up his guys, and they began to fight their way back.  Storming one building, then another.  Pushing the enemy back.  Having to actually shoot up -- at the enemy in the mountains above.  By now, most of the camp was on fire.  Amid the flames and smoke, Clint stood in a doorway, calling in airstrikes that shook the earth all around them.  

Over the radio, they heard comrades who were pinned down in a Humvee.  So Clint and his team unloaded everything they had into the enemy positions.  And with that cover, three wounded Americans made their escape -- including a grievously injured Stephan Mace.

But more Americans, their bodies, were still out there.  And Clint Romesha lives the Soldier’s Creed -- “I will never leave a fallen comrade.”  So he and his team started charging, as enemy fire poured down.  And they kept charging -- 50 meters; 80 meters -- ultimately, a 100-meter run through a hail of bullets.  They reached their fallen friends and they brought them home. 
Throughout history, the question has often been asked, why? Why do those in uniform take such extraordinary risks?  And what compels them to such courage? You ask Clint and any of these soldiers who are here today, and they’ll tell you.  Yes, they fight for their country, and they fight for our freedom.  Yes, they fight to come home to their families.  But most of all, they fight for each other, to keep each other safe and to have each other's backs. 

When I called Clint to tell him that he would receive this medal, he said he was honored, but he also said, it wasn't just me out there, it was a team effort.  And so today we also honor this American team, including those who made the ultimate sacrifice -- Private First Class Kevin Thomson, who would have turned 26 years old today; Sergeant Michael Scusa; Sergeant Joshua Kirk; Sergeant Christopher Griffin; Staff Sergeant Justin Gallegos; Staff Sergeant Vernon Martin; Sergeant Joshua Hardt; and Specialist Stephan Mace.

Each of these patriots gave their lives looking out for each other.  In a battle that raged all day, that brand of selflessness was displayed again and again and again -- soldiers exposing themselves to enemy fire to pull a comrade to safety, tending to each other’s wounds, performing “buddy transfusions” -- giving each other their own blood.

And if you seek a measure of that day, you need to look no further than the medals and ribbons that grace their chests -- for their sustained heroism, 37 Army Commendation Medals; for their wounds, 27 Purple Hearts; for their valor, 18 Bronze Stars; for their gallantry, 9 Silver Stars. 

These men were outnumbered, outgunned and almost overrun.  Looking back, one of them said, “I’m surprised any of us made it out.”  But they are here today.  And I would ask these soldiers -- this band of brothers -- to stand and accept the gratitude of our entire nation.  (Applause.)

There were many lessons from COP Keating.  One of them is that our troops should never, ever, be put in a position where they have to defend the indefensible.  But that’s what these soldiers did -- for each other, in sacrifice driven by pure love.  And because they did, eight grieving families were at least able to welcome their soldiers home one last time.  And more than 40 American soldiers are alive today to carry on, to keep alive the memory of their fallen brothers, to help make sure that this country that we love so much remains strong and free. 

What was it that turned the tide that day?  How was it that so few Americans prevailed against so many?  As we prepare for the reading of the citation, I leave you with the words of Clint himself, because they say something about our Army and they say something about America; they say something about our spirit, which will never be broken:  “We weren't going to be beat that day,” Clint said. “You're not going to back down in the face of adversity like that.  We were just going to win, plain and simple.”

God bless you, Clint Romesha, and all of your team.  God bless all who serve.  And God bless the United States of America.

With that, I’d like the citation to be read.

MILITARY AIDE:  The President of the United States of America, authorized by Act of Congress, March 3rd, 1863, has awarded in the name of Congress the Medal of Honor to
Staff Sergeant Clinton L. Romesha, United States Army, for conspicuous gallantry and intrepidity at the risk of his life above and beyond the call of duty:

Staff Sergeant Clinton L. Romesha distinguished himself by acts of gallantry and intrepidity at the risk of his life above and beyond the call of duty while serving as a Section Leader with Bravo Troop, 3rd Squadron, 61st Cavalry Regiment, 4th Brigade Combat Team, 4th Infantry Division, during combat operations against an armed enemy at Combat Outpost Keating, Kamdesh District, Nuristan Province, Afghanistan on October 3rd, 2009. 

On that morning, Staff Sergeant Romesha and his comrades awakened to an attack by an estimated 300 enemy fighters occupying the high ground on all four sides of the complex, employing concentrated fire from recoilless rifles, rocket propelled grenades, anti-aircraft machine guns, mortars and small-arms fire.  Staff Sergeant Romesha moved uncovered under intense enemy fire to conduct a reconnaissance of the battlefield and seek reinforcements from the barracks before returning to action with the support of an assistant gunner. 

Staff Sergeant Romesha took out an enemy machine gun team, and, while engaging a second, the generator he was using for cover was struck by a rocket-propelled grenade, inflicting him with shrapnel wounds.  Undeterred by his injuries, Staff Sergeant Romesha continued to fight, and upon the arrival of another soldier to aid him and the assistant gunner, he again rushed through the exposed avenue to assemble additional soldiers. 

Staff Sergeant Romesha then mobilized a five-man team and returned to the fight equipped with a sniper rifle.  With complete disregard for his own safety, Staff Sergeant Romesha continually exposed himself to heavy enemy fire, as he moved confidently about the battlefield engaging and destroying multiple enemy targets, including three Taliban fighters who had breached the combat outpost’s perimeter. 

While orchestrating a successful plan to secure and reinforce key points of the battlefield, Staff Sergeant Romesha maintained radio communication with the tactical operations center.  As the enemy forces attacked with even greater ferocity, unleashing a barrage of rocket-propelled grenades and recoilless rifle rounds, Staff Sergeant Romesha identified the point of attack and directed air support to destroy over 30 enemy fighters. 

After receiving reports that seriously injured soldiers were at a distant battle position, Staff Sergeant Romesha and his team provided covering fire to allow the injured Soldiers to safely reach the aid station. Upon receipt of orders to proceed to the next objective, his team pushed forward 100 meters under overwhelming enemy fire to recover and prevent the enemy fighters from taking the bodies of their fallen comrades. 

Staff Sergeant Romesha’s heroic actions throughout the day-long battle were critical in suppressing an enemy that had far greater numbers.  His extraordinary efforts gave Bravo Troop the opportunity to regroup, reorganize and prepare for the counterattack that allowed the Troop to account for its personnel and secure Combat Outpost Keating. 

Staff Sergeant Romesha’s discipline and extraordinary heroism above and beyond the call of duty reflect great credit upon himself, Bravo Troop, 3rd Squadron, 61st Cavalry Regiment, 4th Brigade Combat Team, 4th Infantry Division and the United States Army.

(The Medal of Honor is awarded.)  (Applause.)

THE PRESIDENT:  Well, thank you, everybody.  Most of all, thank you for Clint and the entire team for their extraordinary service and devotion to our country. 

We're going to have an opportunity to celebrate and there’s going to be a wonderful reception -- I hear the food around here is pretty good.  (Laughter.)  I know the band is good.  And Colin really needs to get down.  (Laughter.) 

So, enjoy, everybody.  Give our newest recipient of the Medal of Honor a big round of applause once again.  (Applause.)

END 
2:10 P.M. EST

Extending Middle Class Tax Cuts

Check out all the ways you can get involved with President Obama's State of the Union Address.

With less than three weeks before devastating, across the board cuts - the so-called "sequester" - are slated to hit, affecting our national security, job creation and economic growth, we must make sure we are having a debate over how to deal with these looming deadlines that is based on facts- not myths being spread by some Congressional Republicans who would rather see these cuts hit than ask the wealthiest and big corporations to pay a little bit more.

President Obama urges Congress to act to avoid a series of harmful and automatic cuts—called a sequester—from going into effect that would hurt our economy and the middle class and threaten thousands of American jobs.

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Tuesday, February 19, 2013

Remarks by the President at Staff Inaugural Ball

The White House

Office of the Press Secretary

Washington Convention Center
Washington, D.C.

9:00 P.M. EST

THE PRESIDENT:  Hello, everybody!  (Applause.)  You all clean up pretty good.  (Applause.)  You are looking good. 

Couple of acknowledgements I want to make -- first of all, please give it up for DJ Mel Sandico.  (Applause.)  The U.S. Army Band is in the house.  (Applause.)  We're so proud -- they can play anything -- anything.  Go ahead and make a request, they’ll play it.  They are outstanding.  And we are so grateful for their service to our country each and every day. 

Now, this is just a little gathering, little party among friends.  (Applause.)  Represented here are our outstanding OFA staff and volunteers.  (Applause.)  Our amazing PIC -- that would be Presidential Inaugural Committee Team.  (Applause.)  

MRS. OBAMA:  This has been a great inauguration.  They've done a great job. 

THE PRESIDENT:  Michelle just said this has been a great inauguration, and you've done a great job. 

We've got the DNC convention team that did an amazing job.  (Applause.)  We've got the DNC team that did an amazing job.  (Applause.)  And we've got the White House team, which is pretty good.  (Applause.)  They did an amazing job.

AUDIENCE MEMBER:  And you!

THE PRESIDENT:  I'm here, too.  (Applause.)  That’s true.  And the First Lady of the United States -- (applause) -- bangs and all -- (applause) -- looking very sparkly and twinkly.  (Laughter.)   

Now, I'm not going to speak long, mainly because I've been speaking a lot and you all have heard me before.

MRS. OBAMA:  And the entertainment is pretty good.

THE PRESIDENT:  And, more importantly, we've got a couple of people who are pretty good musicians named Lady Gaga and Tony Bennett in the house.  (Applause.)  This is like my -- Michelle is like doing interpretive dance of everything I say.  It's been a long weekend -- she's getting a little silly now.  (Laughter.) 
But my main job here tonight is real simple, and it's just to say thank you.  (Applause.)  You know, some of you were involved the very first time I ran, back in 2007, 2008.  (Applause.)  Some of you were 14 at the time, and so just got involved this time out.  (Applause.)  You know who you are.  (Applause.)

MRS. OBAMA:  That’s right.  

THE PRESIDENT:  But regardless of whether you got involved six years ago or you got involved six months ago, what is true is that all of you have come to represent for me and Michelle our deepest hopes for America. 

The average age here is probably around 20-something -- (applause) -- and that’s only because I'm here, which brings the average age up quite a bit.  But when I think about traveling around the country during the course of the campaign and getting to know some of you and meeting some of you and seeing the work you do in the White House or the work that you did during the convention, and I meet young people who are so much smarter and more thoughtful and more caring about the future than I ever was at your age, so much more capable, so much more serious, so much more poised, it makes me know that America’s future is in good hands.  (Applause.)

As long as all of you understand the immense and incredible power that you possess when you work together, when you join voices, when you extend yourselves not just on behalf of your own ambitions but on behalf of a larger cause, you cannot be stopped. And part of the reason I know that America will succeed is when I look at how you work together, what I saw in offices from Vegas  -- (applause) -- to Richmond -- (applause) -- to Colorado Springs -- (applause) -- to Manchester, New Hampshire -- (applause) -- to Orlando, Florida -- it didn’t matter -- (applause) -- it didn’t matter where I was, I'd walk into a volunteer office and what you saw was people from every walk of life -- black, white, Hispanic, Asian, Native American, young, gay, straight -- it didn’t matter where you came from, you came together with a mission in mind and a vision in mind.  And you were willing to set aside whatever surface differences you had because you understood you were working on behalf of an America that was a little more just and a little more fair and a little more compassionate, and better stewards for our environment.  (Applause.)

And seeing that kind of spirit operate day in, day out, no matter how hard the work, no matter how little you got paid, no matter how bad your candidate screwed up, it didn’t matter, you just kept on going.  And there were times during the course of this year where I might have gotten down, but you picked me back up.  (Applause.)  You lifted me up on your shoulders.  And you said, yeah, we know he’s gotten kind of old and gray-haired, and we know sometimes he stumbles.  But we are going to carry him across the finish line.  (Applause.)  Because this is not about him; this is about us.  This is about America.  This is about what we believe.  This is about what our values are.  (Applause.) This is what our ideals are all about.  We are going to go out there and change America.  (Applause.)

That's what you did every single day.  And so this weekend belonged to you.  (Applause.)  To you.  (Applause.)

So my final message -- because I'm already breaking my promise; I said I wasn’t going to talk long -- is to say that you can't stop now.  I know some of you have got to go back to school.  I know some of your parents are all like, okay, you did your little thing, but now you’ve got to go back and get your degree.  I know some of you’ve got some rent to pay, so you’ve got to --

MRS. OBAMA:  Some loans.

THE PRESIDENT:  -- get some loans to repay.  You may be making a whole range of career choices and decisions right now.  And, look, not all of you will end up staying in politics.  Not all of you will end up pursuing professionally public service.  But every single one of you, in your communities, in your neighborhoods, in your workplaces, wherever you decide to put down roots, wherever you decide to make a difference, as long as you retain that spirit that you’ve shown during the course of these campaigns -- the idea that you’re a citizen, that America only works when you make it work -- (applause) -- that you have the power to move this country and, as a consequence, the world  -- if you retain that sense and never lose it, then I tell you, not only is America going to be in good hands, but what’s going to happen is you’re going to influence your peers and your friends and the folks you live next to and your neighbors and people in your workplace.  And suddenly, like Robert Kennedy described, you’re like a stone thrown in a pool and it starts rippling out.  And you don’t know where those ripples are going to go, and that’s the future that I see for you. 

I know that every single person here donated $10 to a memorial on behalf of Alex Okrent Memorial.  (Applause.)  And Alex was one of you -- this incredibly thoughtful, talented, compassionate, caring young person who decided to get involved because he thought he could make a difference.  And tragically, he ended up leaving us while working in the campaign -- some of the people here were there when it happened.  And it was heartbreaking, and it reminded us of how precious our time on this Earth is. 

We don’t have a lot of time.  I know when you’re young it seems like it goes on forever.  It turns out things are fragile. And yet, the thing that outlives each of us is what we do for somebody else, what difference did we make.  And we know Alex made a difference.  (Applause.)  And so his impact outlives him. And that means -- that’s all right -- somebody is over there and they probably fainted because they’ve been standing too long.  Many of you have been at rallies -- there’s one over here, we’ve got EMS folks here.  People, bend your knees while you’re here.  (Laughter.)  And try to get hydrated as well.

MRS. OBAMA:  You know you’ve got to drink some water!

THE PRESIDENT:  Drink water is what I mean.  (Laughter.)  Juice is okay, too.  (Laughter.)

But in the same way that Alex left this indelible mark on my life and Michelle’s life, and many of your lives, you will leave an indelible mark as well, as long as you decide that you’re going to spend your life giving something back. 

You’ve already given me an incredible gift.  You’ve given America an incredible gift.  Don’t stop.  Keep on going.  (Applause.)  Don’t stop.  Stay fired up.  (Applause.) 

Are you fired up?

AUDIENCE:  Fired up!

THE PRESIDENT:  Are you ready to go?

AUDIENCE:  Ready to go!

THE PRESIDENT:  Fired up!

AUDIENCE:  Fired up!

THE PRESIDENT:  Ready to go?

AUDIENCE:  Ready to go!

THE PRESIDENT:  Fired up!

AUDIENCE:  Fired up!

THE PRESIDENT:  Ready to go!

AUDIENCE:  Ready to go!

THE PRESIDENT:  Fired up!

AUDIENCE:  Fired up!

THE PRESIDENT:  Ready to go.

AUDIENCE:  Ready to go!

THE PRESIDENT:  I think Lady Gaga is fired up, too. 

God bless you, guys!  (Applause.)  I love you!  Thank you!  God bless you.  God bless the United States of America.  (Applause.) 

END 
9:16 P.M. EST

Watch: “Fireside Hangout” with Vice President Biden on Reducing Gun Violence

Watch the full video of a Google+ Hangout with Vice President Joe Biden.

President Obama renominates Richard Cordray as Director of the Consumer Financial Protection Bureau.

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