The pharmaceutical industry rightly calls the stage in drug development between basic research and clinical trials the ?Valley of Death.? This is when a potential treatment that?s worked in mice, monkeys, and the like catapults to a phase 1 clinical trial to assess safety. It?s rare.

Francis Collins, MD, PhD, director of the National Institutes of Health, calls this period ?where projects go to die.? The reason: $.

Matthew Herper writes in Forbes that the cost of developing a new drug is $4-11 billion, not the $1 billion that Pharma often claims. Yet even that $1 billion is unimaginable, especially when you put a face on a rare disease and witness what the family goes through to leap to phase 1.

Ginger and Hannah. Photo: Dr. Wendy Josephs

For me, that face belongs to 8-year-old Hannah Sames, of Rexford, New York.

Hannah is one of only 54 people known in the world to have giant axonal neuropathy, or GAN. It?s like ALS (Lou Gehrig?s disease) in a child. Today Hannah needs a walker, but things are going to get worse, much worse ? unless, we all hope, she has gene therapy.

Her parents, Matt and Lori, are making it happen. Since Hannah?s diagnosis in March 2008, they?ve worked nearly around the clock to fund and assemble a team to use gene transfer to deliver the gene that Hannah needs directly into her spinal cord. ?Gene transfer? becomes gene therapy once it works.

Sometime within the next year, a neurosurgeon will delicately place several trillion adeno-associated viruses, each one harboring a working copy of the gene that is mutant in Hannah and seven others, into their spinal cords. If all goes well, the genes will stop the swelling and destruction of the nerves that?s slowly robbing the children of their mobility. And since GAN has no treatments, other than those that ease day-to-day life, it?s worth the gamble. There?s no other option.

Through Hannah?s Hope Fund, the Sames family, and thousands of their neighbors in the capital district of New York, have raised a few million dollars, through events, tee-shirts, races, raffles, everything. They even won two Pepsi refresh grants of $250,000 each. Neighbors of the other GAN families have done the same. But it isn?t enough. The Valley of Death looms.

Hannah?s Hope has funded researchers at Emory University, Columbia University, the University of North Carolina and elsewhere to carry out the steps preceding the gene transfer experiment. And results have been so promising that the Food and Drug Administration (FDA) gave a tentative go-ahead this April, pending further toxicity studies in animals. Those are underway now, but cost $646,000 ? plunging Hannah?s Hope Fund to the breaking point.

Lori estimates other costs:

- $430,200 for a 2-year natural history study for 12 patients to track the course of this ultra-rare disease, so that the researchers can determine exactly what to check to assess success.
- $220,000 to manufacture the viruses and their human gene cargo
- $600,000 for the phase 1, 2-year trial for 8 children
- $450,000 for a small Phase 2 trial to assess efficacy

That?s a total of $2,346,200. Then, hopefully, a biotech or pharmaceutical company will step in for the required larger phase 3 trials that precede FDA approval.

It sounds like a lot. But for comparison?s sake, $2,346,200 equals:

- approximately 1/30th of Johnny Depp?s fee for his next film
- 1/10th of what Alex Rodriguez earns in a year
- 10 speeches for Bill Clinton
- 6 of Kate Middleton?s wedding dress
- 2 years worth of nanny-time for Brad and Angelina?s brood
- Slightly more than Kim Kardashian?s useless $2 million engagement ring
- .07% of the money spent on the Obama and Romney campaigns as of March 2012.

The government isn?t funding the GAN gene therapy trial. So what the tiny GAN community needs, desperately and now, is a Michael J. Fox, Christopher Reeve, or Julia Roberts.

Lori and Hannah Sames. Photo: Dr. Wendy Josephs

What the pharmaceutical industry and public health community need, for the long-term, is a new way of treating disease, such as gene or stem cell therapy. ?A one-time treatment that is effective would reduce or eliminate long-term supportive care, which is certainly in the interest of public health and reducing overall health care costs,? says Steven Gray, Ph.D., the researcher at UNC who?s engineering the viruses for the GAN trial.

Lori Sames explains it. ?Gene therapy is a disruptive technology to the pharmaceutical industry and is likely the solution for many ravaging disorders. We need help funding these proof-of-concept trials to help get gene therapy mainstream. We need help restructuring Pharma for these expensive, one-time treatments. What is the business model? How do you price it so payers will reimburse, yet be able to attract investors to develop the gene therapies??

I usually find new medical phrases awkward or unnecessary, like ?erectile dysfunction? or ?histamine blocker,? but ?disruptive technology? is neither new nor meaningless. It perfectly describes gene therapy.

James Wilson, MD, PhD, professor of pathology and laboratory medicine at the University of Pennsylvania and a leader in the gene therapy community, in a recent editorial in Human Gene Therapy, credited Harvard economist Clayton Christensen with originating the term in the mid 1990s.

A disruptive technology has no track record yet has the very real potential to have a huge impact, possibly pushing aside established approaches ? like iTunes. In contrast, a sustaining technology improves what?s already available. And a gene therapy that works, as is the case for two types of hemophilia, for example, instantly renders obsolete costly protein replacement. In fact, a new journal from Mary Ann Liebert, Inc., Disuptive Science and Technology debuts this month, providing a forum for reports on such innovative approaches.

Meanwhile, if funding materializes, Hannah and the other seven kids will have their gene therapy in early 2013, halting the inexorable jamming of their motor neurons. And the novel delivery to the spinal cord will pave the way for more common conditions, such as ALS, spinal muscular atrophy, and even spinal cord injuries.

?This would be the first gene transfer trial that we are aware of to treat the whole spinal cord. And everything up until now has been funded by private donations,? says Dr. Gray.

But all of the private donations aren?t enough.

Please help Hannah, or any of the other 30 million people in the U.S. and those elsewhere suffering from rare diseases.

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The non-stick tech is FDA approved and ready to be used in industry immediately

It's the world's biggest non-problemic problem: getting the last bit of ketchup out of the jar. Ketchup is so viscous, and it seems so eager to stick to glass and plastic. But leave it to students at the?Massachusetts Institute of Technology to solve the greatest non-issues of our generation: A team of engineers have designed the perfect condiment bottle ? one that ketchup simply cannot stick to.

The secret is in a?futuristic substance known as "LiquiGlide," a non-toxic, FDA-approved coating that can be applied to the interior of bottles. According to MIT PhD candidate Dave Smith, it's "kind of a structured liquid ? it's rigid like a solid, but it's lubricated like a liquid." Regardless of what the bottle is constructed of, liquid or plastic, ketchup will flow out of it nearly effortlessly.

It seems like ketchup sticking to the inside of bottles is a more compelling problem than many realize ? a rival team at nearby Harvard University have been working on?similar, plant-derived, ketchup bottle technology. And the idea of a friction-less ketchup bottle caught enough people's imaginations to win the audience choice award at the?MIT $100K Entrepreneurship Competition.

Ending bottle friction is a noble goal. Any technology to get ketchup out of bottles easier could make a serious dent in helping reduce food waste in a $33 billion condiment industry. Smith explains that the new bottles "could save one million tons of food from being thrown out every year."

Interestingly enough, LiquiGlide wasn't initially designed to be used for ketchup ? the original idea had the coating being used as an anti-icing coating, or a pipe coating that might help reduce oil and gas clogs. But as Smith explains, "most of these other applications have a much longer time to market; we realized we could make this coating for bottles that is pretty much ready. I mean, it is ready."

MIT via?Fast Company

This article was written by Fox Van Allen (Twitter) and originally appeared on Tecca

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A large majority of Americans support a pair of congressional efforts to create an economy based on cleaner-energy sources, according to the latest United Technologies/National Journal Congressional Connection Poll.

Almost two-thirds?64 percent?of those surveyed said that Congress should extend federal tax credits that encourage production of alternative-energy sources, such as wind, that are due to expire at year?s end. In a separate question, 64 percent of respondents said they support enactment of a clean-energy standard, which would require the country to produce a higher percentage of its electricity from cleaner sources of energy.

The United Technologies/National Journal Congressional Connection Poll, conducted by Princeton Survey Research Associates International, surveyed 1,004 adults by landline and cell phone from May 17-20, 2012. It has a margin of sampling error of +/- 3.6 percentage points.

The poll?s findings indicate a disconnect between what the public says it wants and what this Congress is able or willing to do on energy policy, which in an election year is mostly nil.

In a visit on Thursday to Iowa?the country?s second-largest wind-producing state after Texas?President Obama will urge Congress to extend a key production tax credit for wind and a clean-energy manufacturing credit. Congress is unlikely to consider these tax credits until year?s end when lawmakers take up the annual ?tax-extenders? package. Whether congressional supporters of the tax credits, including senior Republican Sen. Chuck Grassley of Iowa, can muster enough support to extend the credits remains uncertain and likely depends on the outcome of the elections. Action this year on a clean-energy standard measure introduced by retiring Senate Energy and Natural Resources Chairman Jeff Bingaman, D-N.M., is very unlikely no matter how Election Day goes.

While support for these clean-energy policies was predictably stronger among Democrats and independents than Republicans, respondents identifying with the GOP were split. Almost half of Republicans said they support extending clean-energy tax credits (48 percent) and enacting a clean-energy standard (47 percent). That support is not reflected in Washington, where most congressional Republicans shun clean-energy policies, especially an energy mandate, in favor of less government involvement and reducing the deficit.

Support for the two policies was higher among blacks and Hispanics, younger people, and earners making less than $30,000 a year. For example, 61 percent of whites said they support extending clean-energy tax credits, but 72 percent of Hispanics and blacks said they do. Just over three-quarters of respondents between ages 18 and 29 said they support extending the tax credits, while 54 percent of respondents older than 50 said they do.

Although Washington and the public appear disconnected on clean-energy policy, they?re more united on another key energy issue: hydraulic fracturing, or ?fracking,? a controversial technology used to develop deposits of shale natural gas and oil recently discovered in many regions of the country.

A slight majority of Americans are aligned with the Obama administration?s recent action to regulate fracking, according to the survey: 53 percent said they support increasing federal regulation of fracking; 25 percent said they support decreasing federal regulations to encourage more natural-gas production. Only 15 percent said that the country should completely ban fracking because of the environmental concerns, including worries that it could contaminate drinking-water supplies and worsen climate change.

The administration is very unlikely to support a complete ban on fracking. But it has in the past month announced two regulations, including one to cut air emissions from fracking and another requiring companies drilling on public lands to disclose the chemicals they use. The federal government has in the past left fracking regulation to states, but the shale-gas boom and escalating environmental concerns have prompted the administration to step in.

Majorities of Democrats (60 percent) and independents (55 percent) said that the federal government should increase regulations, while almost a quarter (24 percent) of independents agreed with 41 percent of Republicans that the government should decrease regulations to stimulate more energy production.

Respondents in the East, which includes Appalachian states such as Pennsylvania that are ground zero for the shale-gas boom, are the least supportive of fracking. But even there, only 18 percent back a complete ban. Exactly half support increasing federal regulations.

Meanwhile, Americans seem the most divided over what Washington should do with the impending automatic cuts of $600 billion in both domestic programs and defense spending, which Congress agreed last summer to impose at year?s end if it couldn?t reach an agreement to reduce the deficit.

A plurality (41 percent) said that Congress should uphold the original agreement to equally balance the cuts between defense and domestic programs, but another 26 percent said that Congress should cut more from domestic programs and less from defense. Yet another 20 percent said Congress should strike the entire deal and not impose any cuts at all.

A majority of Democrats (54 percent) said that the agreement should stay as is, but fewer independents (43 percent) and Republicans (32 percent) agreed with that position. Almost half (44 percent) of Republicans said that more cuts should come from domestic programs to preserve defense spending. Respondents with a high school degree or less seemed to be the least supportive of keeping the agreement as it is?just 36 percent supported the status quo.

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French President Francois Hollande arrives for an EU summit at the EU Council in Brussels, Wednesday, May 23, 2012. The leaders of the 27 countries that make up the European Union are to meet in Brussels Wednesday to try and find a way to keep the debt crisis in Europe from spiraling out of control and promote jobs and growth. (AP Photo/Geert Vanden Wijngaert)

French President Francois Hollande arrives for an EU summit at the EU Council in Brussels, Wednesday, May 23, 2012. The leaders of the 27 countries that make up the European Union are to meet in Brussels Wednesday to try and find a way to keep the debt crisis in Europe from spiraling out of control and promote jobs and growth. (AP Photo/Geert Vanden Wijngaert)

German Chancellor Angela Merkel arrives for an EU summit at the EU Council in Brussels, Wednesday, May 23, 2012. The leaders of the 27 countries that make up the European Union are to meet in Brussels Wednesday to try and find a way to keep the debt crisis in Europe from spiraling out of control and promote jobs and growth. (AP Photo/Geert Vanden Wijngaert)

French President Francois Hollande, left, shakes hands with Spain's Prime Minister Mariano Rajoy prior to their meeting at the Elysee Palace, Paris, Wednesday, May 23, 2012. (AP Photo/Jacques Brinon)

BRUSSELS (AP) ? European Union leaders concluded their latest summit with few concrete steps to fix the continent's festering financial crisis even as the potential for a messy Greek exit from the euro appears to be rising. Some leaders stressed the importance of planning for just such an event but offered no measures that might help Greece avoid it.

Also left unresolved was what Europe should do to spark economic growth and restore investors' confidence. The fiscal austerity agenda that Germany has promoted as the solution to Europe's problem of too much government debt has been met with rising skepticism in European capitals. Yet the summit proved that any significant alternatives ? bonds issued jointly by euro nations or more forceful action by the European Central Bank ? will be difficult to push through.

The politicians did however give the main EU institutions such as as the European Investment Bank the task of drawing up proposals for growth in time for another summit in June.

The perception that European leaders lack the political will to tackle the continent's financial and economic problems has left markets on edge for weeks. Recession is spreading and government borrowing costs are on the rise across much of Europe, making it harder for heavily indebted countries to finance their deficits. The biggest fear is that if Greece cannot be saved, other larger economies ? like Spain or Portugal ? might face the same fate.

The eurozone countries "have to consider all kinds of events," Luxembourg Prime Minister Jean-Claude Juncker told reporters after a European Union summit, but insisted that "the working assumption" was that Greece would remain part of the euro. Leaders gathered in Brussels recognized that Greece had endured significant hardships and promised to release development funds aimed at spurring growth.

But the statement from Juncker, who also chairs meetings of eurozone finance ministers, was a frank admission that Greece could wind up abandoning the euro ? especially after fringe political parties that are threatening to renege on commitments made to secure bailout loans saw their popularity surge in recent elections. No party has been able to form a government, and the country will vote again June 17.

Many analysts fear a Greek exit would cause investors to doubt the financial viability of other weak members that use the currency and create global financial panic. Others have said that Greece, already in its fifth year of recession, has no hope of recovery if it sticks to the spending cuts and tax hikes it agreed to in order to secure bailout loans.

"We want Greece to remain in the euro area," German Chancellor Angela Merkel said after the meeting. "We expect that they will stick to the commitments that they have entered into."

Political uncertainty in Greece is just one of the fires the Europe needs to put out. Leaders are also facing rising borrowing costs in Spain and Italy that could force them to seek bailouts and sluggish growth across the region exacerbated by budget cuts meant to reassure markets about high debt levels.

But the meeting was short on answers, even as leaders described a wide-ranging discussion that touched on ways to boost growth and ensure that the debt crisis, which has eaten away at Europe's economies and confidence in their currency for more than two years, never recurs.

Markets had expected the summit to disappoint and it did. Europe's stock markets had fallen heavily during trading on Wednesday and the euro hit a near two-year low against the dollar.

Asian stock markets struggled to make headway early Thursday as the lack of a breakthrough in Europe unnerved traders. Japan's benchmark Nikkei 225 was marginally down at 8,550.62 while Hong Kong's Hang Seng Index fell 0.2 percent to 18,749.19.

Dariusz Kowalczyk, senior economist at Credit Agricole CIB in Hong Kong, said Thursday: "Europe is not doing enough, and the market may not wait for them."

One of the biggest questions facing Europe is whether it's time to cut Greece some slack. Some European countries seemed ready to ease the pressure, and international organizations have called for the pace of austerity measures to be slowed in some struggling countries.

But the Thursday's summit of 27 European Union leaders ended with no apparent concessions. A final statement said Greece had to respect its commitments and trumpeted the money the Eurozone and the International Monetary Fund had loaned Greece as a sign of their "solidarity." It did say that funds for economic development would be sent to Greece ? though it's unclear how much of an immediate impact on growth they would have.

Juncker insisted early Thursday that he had not asked the euro nations to prepare national contingency plans for a possible chaotic departure of Greece from the currency.

French President Francois Hollande said that to evoke the even the possibility was dangerous ? and would send a signal to the markets that the eurozone wasn't standing behind Greece.

The debate reflects the fine line European leaders must walk between pressuring Greece to stick to a program of spending cuts and tax hikes that have exacerbated its economic slowdown and trying to ensure its presence in the eurozone.

Spanish Prime Minister Mariano Rajoy suggested the European Central Bank resume some of its emergency measures, such as buying the bonds of weak countries, which has the impact of lowering countries' borrowing rates. The ECB has suspended the purchases because, as an independent body, it does not want to be seen supporting governments directly. Instead, it has given European banks massive amounts of cheap loans to bolster confidence in the financial system and allow banks to buy up their country's debt.

Leaders on Thursday also addressed the contentious issue of whether the countries that use the euro should spread the risk and borrow money jointly ? issuing so-called "eurobonds." This would mean every country could borrow funds at the same rate, substantially lowering the costs for the more indebted countries.

Hollande has pushed for them as an important way to ensure such a crisis never happens again, but Merkel has rejected them, fearing they would reduce the pressure on heavily indebted governments to heal their finances and force Germany to borrow at higher rates.

___

Don Melvin also contributed to this story.

Associated Press

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SANAA (Reuters) - Yemeni soldiers marched in a National Day parade on Tuesday as the president watched from behind a bullet-proof glass shield in a show of defiance after a bomber killed more than 90 troops in an attack on the ceremony's rehearsal.

A somber mood hung over the event, meant to celebrate the 1990 unification of north and south Yemen, but it passed off without any repeat of Monday's bloodshed despite militant threats to carry out more attacks.

The bombing, one of the deadliest in Yemen in recent years, was a setback in its battle against Islamists linked to al Qaeda and heightened U.S. concerns over a country in the front line of Washington's global war on militants.

Al Qaeda in the Arabian Peninsula (AQAP) and its affiliate Ansar al-Sharia (Partisans of Islamic Law) both claimed responsibility.

Heavy security surrounded President Abd-Rabbu Mansour Hadi and senior civilian and military officials as they watched Tuesday's parade, which was moved from the scene of the attack at Sabaeen Square to the air force academy in Sanaa.

Hadi, who took over after former President Ali Abdullah Saleh surrendered power in November following months of protests against his 33-year rule, told victims' families on Monday that the fight against al Qaeda would carry on undaunted.

"The war on terrorism will continue until it is uprooted and annihilated completely, regardless of the sacrifices," Hadi said, quoted by the state news agency.

Patrols were stepped across the city and dozens of policemen stood guard at street intersections. Few people ventured out, partly due to the holiday and partly for fear of more attacks.

"We are sad for our comrades, but al Qaeda will not scare us," said Khaled al-Ansi, a soldier stationed at a street corner in central Sanaa.

The huge explosion, carried out by a man in a military uniform in the middle of the tightly-packed parade rehearsal, killed more than 90 people and wounded at least 220, according to the Defence Ministry.

One Yemeni investigator said the bomber was probably a rogue soldier recruited by al Qaeda.

Turkish Ambassador Fazli Corman, who attended the ceremony, told Reuters: "Everyone was relieved at the end that it went safely, there was not a celebratory atmosphere, it was solemn."

"All the foreign ambassadors were there, it was a strong message of solidarity," he said.

Hamoud Al-Hitar Hitar, an expert on Islamist groups, said the incident showed how dangerous and organized al Qaeda was as it was able to reach into the heart of the army.

"Al Qaeda now have a large and strong stock-pile of weapons including tanks, rockets, Katyushas. All that they are missing are planes," he said.

A similar attack was likely to happen again, he said.

Saeed Obaid, a Yemeni researcher of Islamist groups, said al Qaeda wanted to control all Yemen and to spread its influence across the Middle East.

"Al Qaeda will definitely continue to perpetrate these terrorist attacks but they are unlikely to be on such a grand scale," he told Reuters. "The point al Qaeda made through yesterday's attack was to flex its muscles and show its strength."

U.S. CONCERN

At a NATO summit in Chicago on Monday, U.S. President Barack Obama said he was very concerned about extremist activity in Yemen and pledged more aid to counter it.

"That's important for U.S. safety. It's also important for the stability of Yemen and the region," Obama said.

His counter-terrorism adviser, John Brennan, telephoned Hadi to offer U.S. help in the investigation, saying Washington "would stand by Yemen's side at this difficult time", the White House said.

Washington is increasing its support for Hadi's government and the U.S. military has targeted militants in Yemen with drones, which have frequently killed civilians and are deeply resented by Yemenis, even the many who abhor al Qaeda.

A diplomatic source in Yemen said that between 60 and 70 U.S. military experts have arrived in Yemen from Bahrain over the past two weeks to help in the fight against al Qaeda.

A U.S. military trainer was seriously wounded in an ambush on Sunday claimed by Ansar al-Sharia. An official U.S. figure for current military aid was not available.

Exploiting turmoil resulting from the months of protests that helped topple Saleh, militants have seized swathes of territory in the south and threaten shipping lanes in the Gulf of Aden and the Red Sea.

The AQAP said the parade attack was in response to the "crimes" of the security forces in southern Abyan province.

Yemeni troops had closed in on the southern militant-held town of Jaar on Sunday, part of a new U.S.-backed offensive launched this month to regain control of territory and towns seized by Ansar al-Sharia.

(Additional reporting by Tom Finn and Layla Maghribi; Editing by Angus MacSwan)

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Browser dependent strategy MMO games having economy themes might be played totally free. Merely sign up your reputation along with your e-mail address to develop a personality and you can begin actively playing following the video game loads. You may also devote actual money to order distinctive items however, if you are on a tight price range, the thing that you need to devote can be your time.

Just like much of the tactic MMO video games on the web, you can utilize your experience points to enhance the relevant skills of your character. As an illustration, if the personality concocts potions for a living, you are able to boost his pace, stamina or intelligence to ensure that they can produce more potions for other gamers. To get wealthy, you have to sell your service towards the various other players in order to business businesses.

Discover much more to gain greater experience. With more experience, you will ultimately acquire more cash to run and power up your electronic business at strategy jeu gratuit.

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Do you think a pair of athletic glasses is a necessary in the course of doing sport? If you answer is no, I bet you haven't encountered some unexpected occasions, or maybe thing is that you are not that into doing sport. Personally, I think athletic glasses are one of the most practical equipments for sport lover as well as professional athletes.

If a sport guy has bad vision, it is a must for him to get a pair of prescription athletic glasses. As an indispensable item in sportsmen's equipment, athletic glasses have versatile functions, which not only can offer you a good vision, provide you protection, but also give you a deadly cool look! There is no surprising why so many sportsmen love to wear it.

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Purchasing a pair of good athletic glasses, you need take two dimensions into consideration, which are comfort as well as its UV protection.

Many sportsmen have the same experience that their athletic glasses easily slip off their face in the course of doing sports. Therefore, it is vital for a sportsman to select a pair of athletic glasses fit best. Too tight and too loose would do no good to your comfort. In addition, a pair of high-qualified athletic glasses also provides wearers an effective UV protection, which can oblige to block out detrimental rays and to achieve a perfect protection. When doing sports, being exposed to sun is inevitable, thus, a pair of athletic glasses with the function to block rays is a must!

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A surging amount of people reject to accept of a pair of athletic glasses for the reason of high price. Okay! That is a problem exactly. But today, purchasing online will help you to fetch athletic glasses with lower price. And also, there are a lot of cheap glasses and sunglasses there. So, check it yourself!

Have ever thought about free eyeglasses or got free ones? If the answer is negative, a piece of good news will perk you up. An optical online store called Firmoo offers free glasses of trendy styles and attractive colors waiting for you. In details, free glasses include free frame, 1.50 single vision lenses and complimentary accessories. The way of getting free glasses is too simple to believe. You only visit their site and you will get the chance to buy you a pair of free glasses. By the way, free eyeglasses are available for first-time customers of firmoo only. One pair per person. Excited about this? Free prices don't mean inferior quality. It is said that lots of glasses wearers have got much benefits from these high quality eyewear. What comes to your mind while getting to know these free eyeglasses?

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