Although we don't believe in timing the market or panicking over daily movements, we do like to keep an eye on market changes -- just in case they're material to our investing thesis.

The S&P 500 Index reached the psychologically meaningful 1,800 level in early trading Monday as the stock market continued to rally higher. With the notable exception of the debt ceiling and budget issues, which peaked last month, Wall Street has been mainly focused on the future of Federal Reserve stimulus efforts. Since Janet Yellen -- the new nominee to replace Chairman Ben Bernanke at the central bank -- spoke last week and reiterated her support for loose money policies, little else has moved the market. With a dearth of catalysts, the S&P 500 fell from earlier highs, losing six points, or 0.4%, to end at 1,791. 

Casino game maker International Game Technology ended toward the bottom of the benchmark index, falling 5.6%. Shareholders got a healthy taste of good and bad news last week. The company boosted its quarterly dividend to $0.11 per share, up from $0.10 per share. The annual yield now sits at 2.6%, or roughly the return of the 10-year Treasury yield. At the same time, a number of big-name Vegas casinos are transitioning from slot machines to more lucrative games as casinos revamp to make each square inch of real estate do its best ATM impression. 

Shares of North American grocery store Safeway lost 4.3% as grocers begin to feel the effects of falling food-stamp funding by the federal government. The funding increase for food stamps, known as SNAP benefits, expired on November 1, and will likely hit the top and bottom lines of grocers that accepted them. Of the seven publicly traded U.S. grocers worth more than $2 billion, not a single one advanced today, and Goldman Sachs even went so far as to downgrade one of Safeway's competitors, SUPERVALU.

Lastly, coal miner Peabody Energy slumped 3.7%. A painful decline in stock price is nothing new for coal miners or Peabody Energy, in particular, as both prices and demand have fallen with the shift from coal to cleaner energy alternatives like natural gas. Regulatory pressure is also hurting the prospects for coal miners: The White House is taking concerted actions to prevent "dirty" coal from being used in new power plants. With Peabody boasting no trailing earnings and facing an uphill battle against competitive energy sources and governmental regulations, this stock just doesn't have much going for it right now. 

Although we don't believe in timing the market or panicking over daily movements, we do like to keep an eye on market changes -- just in case they're material to our investing thesis.

Dow 16,000 and S&P 1,800 turned out to be intraday events only on Monday, as markets fell steadily from their early gains. The S&P 500 and Nasdaq actually turned negative on the day, and the Nasdaq's loss of almost 1% reflected losses in several major momentum stocks. Tesla Motors , Yelp , and SUPERVALU were all posed severe losses of as much as 10%. Let's take a closer look at why these stocks dropped so much today.

Tesla dropped more than 10%, hitting its lowest level since July as the automaker faces an investigation at its Model S plant in California following an accident there that injured three workers. Combined with multiple incidents of fires following car crashes, Tesla has faced an unusual amount of negative publicity, and that has erased the momentum that the electric-vehicle manufacturer carried throughout so much of 2013. With potential shareholder lawsuits possibly coming in the near future and word pending on whether Tesla will have to recall vehicles, investors need to prepare for more volatility.

Yelp declined 9% in sympathy with other social media websites, including Facebook and Twitter , both of which dropped 6.5%. As with Tesla, Yelp and its social brethren have been among the biggest gainers recently, with Yelp having quadrupled so far in 2013 on the perceived promise of its restaurant and services review service. Yet as nervous investors start looking for reasons that the stock market could correct, high-flying stocks like Yelp are natural targets for taking profits to preserve hard-won gains this year.

SUPERVALU also fell 9%, with Goldman Sachs downgrading the grocery retailer. Among potential downsides that Goldman cited were cuts to the food-stamp program, which could affect the amount of discretionary income shoppers have to buy food from its store chains. Given the fragility of SUPERVALU's recovery after its massive split-off from many of its former chains, including Albertson's and Osco, it's reasonable that shareholders are pulling back from the stock, which is still up 150% on the year.

Source: DC Entertainment.

While Marvel and Walt Disney struggle with hardcore fans' desire to see more superheroics in Marvel's Agents of S.H.I.E.L.D., DC Entertainment and Time Warner have upgraded their plans for the Flash.

According to Deadline.com, DC Entertainment and the CW now plan a stand-alone pilot for a show starring Glee actor Grant Gustin in the title role. He was to be introduced in episodes 8 and 9 of Arrow as Central City police investigator Barry Allen and then reemerge as the Flash in episode 20, a backdoor pilot to a potential spinoff series.

Gustin's first two appearances in Arrow as Allen remain on the books. But his first appearance as the Flash will come in the pilot, a decision CW executives made after seeing cuts of him in action in Arrow. Both appearances were "very well received", Deadline reports. For his part, Arrow star Stephen Amell took to his Facebook News Feed to celebrate the news 

Apple  is reportedly close to acquiring PrimeSense, the company whose technology powered the original Microsoft Kinect. An Israeli news outlet reports that Apple made the acquisition for close to $350 million, but AllThingsD believes the deal hasn't been sealed yet. The reports come after the same Israeli outlet reported over the summer that Apple had made a $280 million offer to PrimeSense, so it seems the price tag has gone up since then. Apple has been on quite an acquisitive streak of late, buying 15 companies in fiscal 2013. That's up from its historical norm of swallowing six companies per year.

The most obvious use that Apple may have in mind is for TV gesture controls, much like what Microsoft has done with Kinect. Apple's biggest innovations have always involved interface changes, and the TV interface is in desperate need of some change. Beyond TVs, there are also possible use cases in mobile devices and Macs. Third-party offerings featuring motion controls have garnered some interest recently; just imagine if Apple were to jump in.

In this segment of Tech Teardown, Erin Kennedy discusses Apple's rumored acquisition with Evan Niu, CFA, our tech and telecom bureau chief.

It's the newest game in the arcade: Whack-a-Movil! That's right, it's the game where América Móvil keeps popping up in different places...and gets whacked by the market every time!

Mexico
América Móvil is headquartered in Mexico, and is controlled by Mexican billionaire Carlos Slim. It's also by far the largest mobile provider in Mexico, with more than 61 million subscribers. By contrast, the No. 2 provider, Spanish company Telefónica , only has about 18.5 million subscribers. So you'd think Mexico would have a soft spot for the telecom giant. 

Whack!  You'd be wrong.

In fact, the Mexican government changed its constitution in April to allow regulators to crack down on "dominant" companies with more than 50% of market share in their industry.  America Movil, with 70% of mobile market share, could be forced to sell assets or submit to increased regulation.   As the No. 2 player in this space, Telefónica, stands to benefit big.

Latin America
América Móvil expanded into Latin America, and has seen a lot of success there. It's the No. 1 mobile provider in countries like Colombia, Ecuador, and Nicaragua, and has a presence in most other Central and South American countries as well. 

But in recent years, the Latin American picture has become less rosy for America Movil. Its main rival in this space -- Telefónica again --is besting it in the large South American markets of Brazil, Argentina, Peru, and Chile, and in many of the smaller markets besides. Also, as many people in the region have already acquired cellular service, overall growth in the region has slowed. Whack!

Europe
With its prospects for growth in the Americas fading, América Móvil entered the fractured European market in 2012. It took on a lot of debt to finance the purchases of 24% of Telekom Austria and a 30% stake in Dutch provider KPN. 

Eager to expand América Móvil's European footprint, Slim offered to buy the rest of KPN outright -- a purchase that would have cemented its position in the lucrative German market, but would have also required racking up even more debt. América Móvil's shareholders weren't too enthused.

Unfortunately for América Móvil, the foundation that oversees KPN wasn't enthused either. It went to the extraordinary measure of issuing itself special shares of stock that gave it 51% control of the company, cutting América Móvil's stake in half. Whack!

On October 16, América Móvil announced it was abandoning the offer for KPN and was considering whether or not to sell its current stake. Last week, it also announced it would not attempt a takeover of Telekom Austria. Double whack!! 

And finally, adding insult to injury, expenses related to the debt load from its European obligations nearly halved its overall third-quarter profits, leading to a disappointing earnings report on October 25. Triple whack!!!

Meanwhile, Telefónica is already a big player in Europe and is waiting on regulatory approval to expand its German operations.  

India
After taking a lot of whacks elsewhere in the globe, you might think that Carlos Slim would hunker down for a while and concentrate on his core markets. Not so, according to some recent reports. America Movil may pop up next in India.

As part of its plans to purchase UK-based cellular behemoth Vodafone , US-based cellular behemoth AT&T is examining what their combined operations might look like. And it doesn't like what it sees in India and Africa.

According to Bloomberg, AT&T is considering selling Vodafone's India and Africa assets in order to concentrate on Europe. The most likely buyers? China Mobile or...América Móvil.  However, China and India have had a rocky relationship over the years, so América Móvil may actually have an advantage over China Mobile in securing Vodafone India's 155 million subscribers.

You read that right: 155 million subscribers. América Móvil currently has only 210 million subscribers in North and South America combined!  This potential purchase would almost double its operations...but at what cost?

India is a huge market, with more than a dozen cellular providers.  Contrast that to the countries of Europe and South/Central America, most of which have four or fewer providers.  Obviously, there's a massive market opportunity in India, but there's also massive competition.

Plus, this acquisition would also have to be financed through debt, of course.  And América Móvil's shareholders are pretty wary of its debt load already; the stock jumped 4%. Various news outlets have reported between 3.5% and 6%. on the news that its debt-financed bid for KPN was abandoned. Incidentally, I think AT&T's shareholders should likewise be wary of its debt load if it moves to purchase Vodafone. 

Which brings me to my next point: All of this is contingent on AT&T's successful purchase of Vodafone, which is looking more and more likely, but as with any purchase involving the government regulators of dozens of countries, will take time. 

And it's likely to be an uncomfortable wait for América Móvil shareholders as the stock price continues to hemorrhage and the company continues buying back shares to keep the price afloat.  I'd stay out of this one, or the next thing getting Whacked might be your portfolio. Interested in international telecom?  Try Telefónica or Vodafone instead.

Although we don't believe in timing the market or panicking over daily movements, we do like to keep an eye on market changes -- just in case they're material to our investing thesis.

Although the Dow Jones Industrial Average traded above 16,000 today, investors didn't have the confidence to keep the blue-chip index above that threshold for the whole trading session. The index closed the day up 14 points, or 0.09%, to sit at 15,976. The same goes for the S&P 500, which briefly traded above the 1,800 mark but ended down 0.37% at 1,791.

A number of pundits blamed the moves lower on Carl Icahn. Speaking at the Reuters Global Investment Outlook Summit today, the billionaire activist investor said he can envision a big drop in the markets down the road, as he sees current earnings as being fueled by low borrowing costs, instead of by strong management.

I know a lot of investors closely follow Icahn's words and trades, but he's just one person and he's been wrong before. If you're basing your entire investing thesis on what Carl Icahn has to say, you may have a few more problems to contend with than a future market pullback.  

A few winners and losers
Tyson Foods reported earnings before the market opened today, and shares rose 2.26% on the news. Sales hit $8.9 billion, resulting in earnings per share of $0.70, a 23% increase over the same time last year. EPS also beat analyst expectations by a penny. The company experienced year-over-year growth in four of its major operating segments: chicks sales, up 6.8%; beef, up 9.1%; pork, up 6.3%; and prepared foods, up 9.4%. Management reaffirmed fiscal 2014 revenue of $36 billion after the company finished 2013 at $34.4 billion. Investors should be happy with these results and can probably expect to continue riding this market- beating stock higher in the coming months.  

J.C. Penney once again has made the list of big movers, as shares fell 3.54% today. Investors appear to be growing nervous ahead of the Nov. 20 earnings report, in which earnings per share are expected to come in at negative-$1.72 on revenue of $2.80 billion. That would be 4.4% decline on the revenue side and an 86% collapse on earnings. At this point, no one is actually investing in J.C. Penney: Anyone buying shares now is simply gambling. Until we see some evidence that the company is turning around -- two solid years of positive earnings reports, at a very minimum, would be a good start -- you would be wise to stay as far away from this company as you can.  

Another big loser today was slot-machine maker International Game Technology , which lost 5.61%. There was very little company-specific news today, but investors may be worried about trends in the industry. The University of Nevada Las Vegas Center for Gaming Research recently noted that the number of slots in Las Vegas fell by 38,000 from 2000 to 2012. High rollers -- the kind of people casinos actually make money on -- tend to prefer table games, so slots are being removed to make room for more profitable tables. And the slots that remain can generally accept all types of coins, whereas in the past, they were limited to accepting one kind of coin -- penny slots, nickel slots, and so on. Casinos thus need fewer of the machines. Clearly, that's all bad news for a company that makes slots.

The market hit another all-time high today, opening at 16,000. With the Dow up more than 20% so far this year, fears are mounting that this bull market doesn't have much farther to run. In the lead story from Investor Beat, Motley Fool analysts Jason Moser and David Hanson discuss what investors need to do as the Dow climbs higher.

In this segment from Investor Beat, Motley Fool analysts Jason Moser and David Hanson explain why they're keeping a close watch on shares of Best Buy and Dick's Sporting Goods .

At last month's TUCON 2013 conference, I watched Qualcomm  CEO Paul Jacobs wax poetic over his Qualcomm-designed smart watch. Qualcomm just moved the Toq from the experimental realm to become a real, consumer-focused retail product. You'll be able to buy one on Cyber Monday.

The Qualcomm Toq's key benefits in a couple of bullet points. Image source: Slide from Paul Jacobs' TUCON 2013 presentation.

The Qualcomm Toq may be an early launch, but it's hardly the first smart watch on the market.

• Samsung's Galaxy Gear launched in September to generally poor reviews. The device must be paired with a very limited range of Samsung's own tablets or smartphones, the notifications on the smart watch aren't all that useful (although a recent software update mitigates this problem), and the battery dies too quickly.
• Sony also released a smart watch over the summer, also to terrible reviews. A second take, cleverly named the Sony SmartWatch 2, surfaced in October with somewhat better results. But if this is the first you hear about the Sony smart watch line, you're not alone. If a device is produced and no one buys it, does it even matter?

The Qualcomm Toq hopes to improve on these failed attempts in a couple of ways. The watch is compatible with all Android devices running Ice Cream Sandwich and above, which works out to 72% of all Android devices currently in use. The device should get at least two full days of use out of a single charge, and is replenished by dropping it on a wireless charging pad. And this is the first real product to come with Qualcomm's ultra-low-power Mirasol display technology.

Mirasol screens reflect incoming light instead of relying on LCD-style backlight or even generating its own photons like an OLED screen. The technology is based on research on the optics of butterfly wings. In my view, this is what sets the Toq apart from the Samsung and Sony devices. It walks the delicate line between convenience and battery life.

The Sony watch isn't always on, in order to save battery life. The Samsung watch is always showing a live display but runs out of juice too quickly. This is a play for the middle ground.

Giving his TUCON 2013 speech, Qualcomm CEO Paul Jacobs stops to admire his own Toq smartwatch. Image source: author.

That was a key point in Jacobs' presentation. "When anything happens on my phone, I can get a notification to my wrist," he said. An Android app lets you redirect anything to the watch, as long as it generates a notification on your tablet or phone.

"And you think that's gonna annoy you, but it's on your wrist as opposed to in your phone. It's in my phone, I have to pull the phone out. The screen's dead, I have to turn it on, unlock it, then I finally get what I want. Here, a notification comes to my wrist, I see it and I flick it. It's just gone. I just look at it quickly and it comes and goes."

If the Toq concept fails because the world isn't quite ready for a wrist-mounted information display yet, Jacobs has a backup plan. Mirasol is finally coming to phones, which could unlock similar convenience benefits on a more familiar platform.

"In the future we're gonna take this same kind of display technology and put it on the phone as well," Jacobs said. "Your phone is sitting there on the table looking dead, the screen is off 'cause that uses too much power. That will change in the future, so you will always have the ability to interface with the world around you, with notifications that are coming to you."

It's hard to say whether the Mirasol screen is enough to make the smartwatch concept go mainstream. The watch starts at $350, making it an expensive first-mover status symbol at best. But as a Universal Display investor, I'm sure keeping a close eye on the Toq and other Mirasol launches. This display technology has the potential to steal some of Universal Display's low-power thunder, which would be good news for Qualcomm but bad for Universal Display. If nothing else, the Toq is a useful litmus test for the as-yet unproven Mirasol technology.

On Monday's edition of Investor Beat, host Alison Southwick and Motley Fool analysts Jason Moser and David Hanson take a sharp and irreverent Foolish look at the biggest investing stories of the day.

The market hit another all-time high today opening at 16,000. With the Dow up more than 20% so far this year, fears are mounting that this bull market doesn't have much farther to run. In the lead story from Investor Beat, Jason and David discuss what investors need to do as the Dow climbs higher.

Then, our analysts take a look at four stocks making moves on the market today. Tyson Foods is one hot chicken stock. Boeing makes a huge sale. The Container Store keeps rising, despite not turning a profit. And JPMorgan still can't put the past behind it.

And finally, David and Jason explain why they're keeping a close watch on shares of Best Buy and Dick's Sporting Goods.

Tyson Foods is one hot chicken stock. Boeing makes a huge sale. The Container Store keeps rising, despite not turning a profit. And JPMorgan still can't put the past behind it. In this segment from Investor Beat, Motley Fool analysts Jason Moser and David Hanson offer their take on the stocks making big moves on Monday.

Although we don't believe in timing the market or panicking over daily movements, we do like to keep an eye on market changes -- just in case they're material to our investing thesis.

Stocks closed off their record high today, with the S&P 500 losing 0.4%. However, the narrower, price-weighted Dow Jones Industrial Average did achieve another record high with a 0.1%, respectively. Both crossed psychological levels intraday, 1,700 for the S&P 500 and 18,000 for the Dow, prompting a flurry of warnings that we are in the middle of a stock market bubble.

Some warnings are more legitimate and better-reasoned than others. Speaking at the Reuters Global Investment Outlook Summit on Monday, legendary activist investor Carl Icahn said he is "very cautious" on the stock market, adding that he could see a "big drop" due to the fact that corporate earnings have been goosed more by low borrowing costs than managerial excellence.

Back on September 19, Icahn made it clear just that he is acting on that concern, telling CNBC: "... we're up 30% and yet we have a huge hedge on... I think right now the market is giving you a false picture. I don't think a lot of companies are doing that well. They're taking advantage of low interest rates." The S&P 500 is up 5.1% since then.

Icahn may have a point, though: Low interest rates (and low tax rates) are goosing the bottom line of U.S. companies. That's fine, as far as it goes, but it suggests that "core" profitability isn't as impressive as it appears. To confirm this, I took a look at the last 12 months' EBIT margin for the 420 non-financial companies in the S&P 500; EBIT stands for earnings before interest and taxes, i.e., the company's profits prior to having paid interest and taxes. It turns out that more than 40% of the companies sport current EBIT margins that are lower than their median value over the past 10 years.

Furthermore, low interest rates aren't immutable -- at some point, they will increase, sending interest costs higher and putting pressure on profits. That isn't the end of the story, however: If margins fall, it does not mean stocks will automatically do the same. As Richard Bernstein, of asset allocation firm Richard Bernstein Advisors, noted in July, margins peaked in 1981 and 1982 and declined through the great 1980s bull market. "I don't think history supports the notion that margin compression equates to bear markets," he told Reuters.

Of course, none of this discussion applies to Carl Icahn's favorite idea: Apple . The maker of the iPhone and the iPad only issued its first $17 billion slug of debt in April and, given, the ultra-low rates it obtained, the interest payments are essentially a rounding error compared to its profits. In addition, assuming it keeps a cash cushion, Apple will not need to refinance its debt at maturity. Those profit margins are all-natural -- no performance-enhancement (financial) products used here. (As far for Apple's tax rate is concerned, that's a separate matter altogether. Those are definitely not all-natural.)

While rising interest rates could hurt profit margins -- and stocks along with them - Apple's margins are driven by the quality of its franchise and competition within its industry. The threat of competition is genuine, but at 11.9 times next 12 months' earnings-per-share estimate -- a 22% discount to the S&P 500's multiple -- I know which of Apple shares or the market look the safer bet right now.

Although we don't believe in timing the market or panicking over daily movements, we do like to keep an eye on market changes -- just in case they're material to our investing thesis.

It was almost a banner day for the stock market as both the Dow Jones Industrial Average and the S&P 500 hit milestones of 16,000 and 1,800 for the first time during intraday trading, but faded toward the end of the session. The blue chips up finished up slightly with a gain of 14 points, or 0.1%, while the S&P fell 0.4%.

What cooled off markets was none other than a statement from billionaire investor Carl Icahn. At an investment conference this afternoon, Icahn, who's made a killing this year on Netflix's boom and has also pressured Apple into increasing its share buyback, said: "I'm very cautious on equities today. This market could easily have a big drop." Icahn went on to argue that valuations are high and earnings growth has been driven by low borrowing costs and share buybacks rather than new opportunities and sales increases.

With the broad market up 25% this year thus far, Icahn may have a point. Corporate profits have been boosted by cost-cutting, and a low-interest-rate environment because of the Federal Reserve's stimulus program have made stocks unusually attractive compared with bonds. The S&P's P/E ratio has now reached 19, its highest level since the financial crisis, and well above its long-term average of 15. Profit growth has not been nearly strong as the market might indicate, as S&P 500 earnings are on track to grow just 3.6% this quarter from a year ago.

Turning to individual stocks, Tyson Foods finished up 2.3% after the food processor reported a strong fourth quarter. Tyson said higher chicken sales and a recovery in its beef business helped guide adjusted net income up 23% to $0.70, beating estimates by a penny. Sales of $8.89 billion met expectations. The company reached or surpassed many of its own full-year goals as sales in all categories grew, and management looked forward to a bright 2014. It said it expects domestic meat production to grow by 1% in the current fiscal year and saw input costs falling because of increased grain supplies. Its sales forecast at $36 billion topped the consensus at $35.7 billion, and Tyson lifted its quarterly dividend payout from $0.05 to $0.075, giving it a 1% yield.

Finally, Home Depot will report earnings tomorrow morning, and shares fell 0.5% ahead of the report today. The home-improvement giant is seen as a bellwether for the housing sector, and its report should help shed light on the sector's recent performance, as mortgage rates moved higher in the third quarter. So far, this earnings season has been mostly kind to homebuilders, but Home Depot shares have cooled off after a strong start to the year. Analysts are expecting earnings per share of $0.89 on $19.17 billion in sales when the retailer reports tomorrow.

Google  very likely has a new Nexus 10 tablet in the pipeline to target the full-sized market. Last year's model has been out of stock for weeks, suggesting that a refresh may be imminent. Prior speculation had centered around a device possibly built by Asus, but now rumor has it that LG will be making the new Nexus 10. Both vendors make sense, as each has existing relationships with Google; Asus makes the Nexus 7, while LG makes the Nexus 5. Samsung probably doesn't care much for the Nexus program, since it already enjoys its successful Galaxy lineup of tablets.

Meanwhile, Asus is looking to expand its Google-related product portfolio. After reporting a smaller profit last quarter, Asus said it is planning to launch its first Chromebook early next year, likely to be priced between $200 and $250. Asus also expects to see tablet unit volumes increase depending on how the Nexus 7 fares.

In this segment of Tech Teardown, Erin Kennedy discusses Google's rumored devices with Evan Niu, CFA, our tech and telecom bureau chief.

Questions loom about whether consumer desktop 3-D printers, such as the Stratasys MakerBot or the 3D Systems Cube, are a sustainable revenue streams. Are these printers here to stay? Or are they just fads? If one inventor's enthusiasm for fused deposition modeling, or FDM, desktop 3-D printers is any indication of the sustainability of the category, we may only be scratching the the surface of their potential in the marketplace.

Why it matters
Both the Stratasys MakerBot and 3D Systems Cube lines make up a significant portion of the two companies' revenue streams.

MakerBot Replicator 2, desktop 3-D printer. Source: MakerBot.

Investors widely view Stratasys' acquisition of MakerBot this year as a massive success. Today, MakerBot revenue now accounts for about 9% of Stratasys' revenue. And Stratasys CEO David Reis said in the company's third-quarter press releases that he was "especially pleased by the contribution made by MakerBot." Even more, Reis refers to the desktop 3-D printer category as "one of the fastest-growing segments within our industry." And it's the MakerBot acquisition, he says, that makes Stratasys the "clear leader" in the category.

The 2012-launched Cube line already accounts for about 10% of 3D Systems' revenue. And the line has seen staggering growth, from just $3.3 million in revenue in the third quarter of 2012 to $13.15 million in Q3 today.

Mini Metal Maker creator lauds FDM desktop 3-D printers
Springing on to the 3-D printing community basically overnight, the inventor of the world's first desktop 3-D printer for metal, David Hartkop, has much to say about MakerBot's FDM technology. In fact, the MakerBot inspired the creation of his own printer.

From the heart of the maker culture, Hartkop says these consumer printers are here to stay.

Hartkop went as far as to say that the MakerBot and other desktop FDM printers are often the "centerpiece" for an "emerging do-it-yourself culture."

Fad or here to stay?
Do you agree with Hartkop? Are desktop 3-D printers here to stay? Are we just scratching the surface of their potential in the consumer market?

In this episode of Tech Teardown , Erin Kennedy discusses the latest developments in the tech sector with Evan Niu, CFA, our tech and telecom bureau chief. Among the topivs:

• Sony's PlayStation 4 sold 1 million units upon its release, but should investors be worried about technical glitches?
• What will outgoing Microsoft CEO Steve Ballmer's legacy ultimately be?
• Pandora reports earnings on Thursday. Will the music streaming star be able to show success in scalability?
• It's being reported Apple may have acquired PrimeSense. It this a harbinger of the long-awaited iTV?
• Google's rumored to be getting yet another Nexus tablet out the door.

Shares of BioMarin Pharmaceuticals jumped almost 8% last Friday after the Food and Drug Administration, or FDA, released the briefing documents for the company's enzyme-replacement therapy for Morquio syndrome Type A. The therapy, called Vimizim, is set to be reviewed by an Advisory Committee on November 19^th, with a potential approval by February 28^th of next year.

Mr. Market obviously liked the content of the briefing documents and viewed them as a harbinger for the drug's approval come February. My take on the briefing documents is that they aren't overly positive, but also don't contain any obvious red flags. For instance, the reviewer notes that patients taking Vimizim "reasonably maintained their improvement on the 6 minute walk test...after 72 weeks of exposure." I take this to mean that the FDA views Vimizim as providing a modest benefit to individuals afflicted with Morquio Type A.

Turning to the drug's safety, the FDA reviewer points out that anaphylaxis and hypersensitivity are the major safety concerns for all enzyme replacement therapies, including Vimizim. In the clinical trials, 7.7% of patients receiving Vimizim experienced anaphylaxis and 27% experienced hypersensitivity reactions. Most importantly, there were no deaths in the trials resulting from Vimizim treatment.

Are those bad safety numbers? The answer is no. Vimizim's safety data, in terms of anaphylaxis and hypersensitivity, were in line with other approved therapies. So in short, the market liked the briefing documents because the FDA appears to think the drug provides a clinically meaningful benefit, albeit modest, without undue risks.

Disease Background

Morquio syndrome Type A, is a rare, lysosomal storage disease caused by mutations in the gene encoding for the enzyme that breaks down keratin and chondroitin sulfate. The end result is an accumulation of these metabolic products in multiple organs that typically results in organ failure and frequently death. Patients suffering from this disease usually have skeletal abnormalities and higher than normal keratin sulfate levels in their urine. Fortunately, the disease is quite rare, affecting only about 1 in 200,000 people globally.

Market Opportunity

Because Morquio syndrome Type A is so rare, it's reasonable to wonder if the drug can be commercially successful. What's important to understand is that Vimizim has been granted the coveted Orphan Drug Status, or ODS, by the FDA, as well as the European Medicines Agency. Consequently, BioMarin will enjoy several marketing and tax benefits if Vimizim is approved. On top of that, Vimizim will probably carry a hefty price per dose, which is typical of drugs for rare diseases.

To give investors a better feel for Vimizim's market opportunity, I think a comparison to Sanofi's enzyme-replacement therapy for Pompe disease is helpful. Although Pompe disease affects fewer than 10,000 people worldwide, Sanofi's therapy called Myozyme still generated sales of over $400 million last year.

How did Sanofi achieve such a strong sales number for an extremely rare disease? In large part, pricing. Myozyme costs an average of $300,000 per dose, and insurance companies tend to offer little resistance in terms of reimbursement for rare disorders, despite their hefty price tags. Although Vimizim's exact price hasn't been announced yet, I expect it to be in line with other enzyme-replacement therapies.

How will a Vimizim approval affect BioMarin shareholders?

BioMarin is quickly becoming a leader in the orphan drug game, with four approved therapies already. And if you aren't aware, orphan drugs are big business in the pharma industry. Several big pharmas, for example, are racing to develop their own pipelines for treatments of rare diseases. For companies late to the organ drug game but tons of cash on hand, acquisitions are a good way to play catch-up. Sanofi went this route with their acquisition of Genzyme in 2011, and rumors are swirling that BioMarin is the next buyout candidate.

Roche has specifically been named as an interested party in BioMarin, and was rumored to be raising equity for a takeover earlier this year. Roche CEO Severin Schwan threw cold water on this rumor by stating that he believes that biopharmas in general are simply overvalued at the current time. If Vimizim does get approved as expected, however, I wouldn't be surprised to see Roche or another big pharma throw their hat in the ring for BioMarin's commercial pipeline.

The bottom line for Foolish investors is that Vimizim's potential approval is a big deal for BioMarin, and shares have already started to react accordingly. My take is that Vimizim's approval would push BioMarin even higher, and the buyout talk could start to heat up again.

One incredible growth stock to watch today

Last week, the New England Journal of Medicine published a letter from directors at the Food and Drug Administration clarifying some of the intricacies of its new breakthrough designation for drugs in clinical development. Let's examine how this new designation fits in the context of other expedited approval designations. The differences might seem subtle, but it's important to understand how these labels can impact your investment in a health care company.

Fast-track designation
This designation focuses on therapies that address a serious unmet medical need and allows trial sponsors to interact closely with the FDA in trial design, data analysis, and program development. More importantly, a New Drug Application can be filed in pieces as development progresses, decreasing the time it takes for the drug to reach patients.

One of the most-recent fast-tracked drugs is Alnylam Pharmaceuticals'  Patisiran for the treatment of TTR amyloidosis. Patisiran works by blocking production of the protein that aggregates to cause neuronal and organ failure in patients as young as 2. To date, organ transplants are the only approved treatment, so a pharmacological agent could drastically improve treatment options for this unmet medical need. After a promising phase 2 trial, the FDA hopes that close collaboration with Alnylam will speed phase 3 trials and regulatory filing.

Breakthrough-therapy designation
Breakthrough designation is granted when early stage clinical evidence suggests that the therapy provides a significant improvement in safety or efficacy compared to current standard of care. Like the fast-track designation, this grants drug makers unparalleled access to FDA logistical support as early as phase 1. The goal here is to design trials that expose a minimum number of patients to standard of care therapy in the control group, while maximizing the collection of safety and efficacy data.

According to the letter, 22 drugs received breakthrough designation as of September 30. One drug, Pharmacyclics'  Ibrutinib, gained approval earlier this month. Ibrutinib showed an overall response rate of 68% in an early trial of 111 patients with mantle cell lymphomawho had already been treated with Millenium's Velcade.

Those results prompted the FDA to grant breakthrough designation to promote collaboration, and inevitably to approve the drug after only a phase 2 clinical trial. Analysts estimate that the drugs' improved safety and efficacy profile could make it a $6 billion blockbuster at its peak.

Accelerated approval designation
Accelerated approval is likely the FDA's riskiest undertaking, as it allows a company to file an NDA without long term clinical outcomes studies. Rather, a drug maker may be considered for accelerated approval after trials show a substantial improvement to some surrogate biomarker that is likely to predict clinical benefit. For example, a statin drug might gain accelerated approval after demonstrating a reduction in LDL cholesterol without also showing a reduction in long term cardiovascular risk. This can drastically cut down on the time and cost of clinical development -- if all goes well. 

Sarepta Therapeutics fell victim to the accelerated approval blues last week, when the FDA announced that it would not consider Duchenne muscular dystrophy drug eteplirsen for the special status. Sarepta had considered submitting an NDA in support of etiplersen after a phase 2 trial with only surrogate marker data in 12 patients demonstrating improvements in walking distance and production of the protein dystrophin.

The FDA, however, doubted the validity of that data as a surrogate marker after GlaxoSmithKline and Prosensa's drisapersen failed a late-stage trial. Now Sarepta may be forced to undertake a more robust placebo-controlled study -- a revelation which sent the stock crashing 60%.

Priority review designation
Priority review is granted only after the submission of a NDA to the FDA. The typical time from NDA filing to PDUFA date, or the deadline for an FDA decision, is 10 months; priority review cuts that time to 6 months. This status can be granted to drugs with expedited development under other designations, and is awarded to treatments for serious conditions that dramatically improve upon the standard of care in efficacy and safety clinical trials.

Two of the most discussed drugs of 2013 were granted priority review designation, bumping their PDUFA dates up to early December. These drugs, Gilead Sciences'  sofosbuvir and Johnson & Johnsons'  simeprevir have been widely regarded as revolutions in the treatment of hepatitis C. Both touted as future blockbusters, sofosbuvir has been a major growth driver in Gilead's 87% run year to date, and simeprevir will take the reins in Johnson & Johnson's renewed focus on pharmaceutical growth. More importantly, priority review will allow drugs with sustained viral response rates as high as 100% to reach patients quickly.

The bottom line
It is important to remember that these designations do not guarantee FDA approval, and are based more on getting patients the most promising drugs as quickly as possible. For small unprofitable companies, timing can be critical in the race against cash burn, but be weary of the impact these designations have on long-term growth prospects. Then of course, there is the risks involved in hastily completing development programs. 

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of genetic analysis company Pacific Biosciences of California surged as much as 14% today after an SEC filing on Thursday revealed that Chairman Michael Hunkapiller bought 200,000 shares on the open market.

So what: The stock has slid steadily since its disappointing third quarter in late September, but Hunkapiller's purchase suggests that he knows something specific that Wall Street doesn't or that he simply sees solid long-term value in the shares. After all, as legendary fund manager Peter Lynch once said, "Insiders might sell their shares for any number of reasons, but they buy them for only one: They think the price will rise."

Now what: While sales of Pacific's new gene sequencing system, PacBio RS II, are rather weak at the moment, shareholders could be rewarded handsomely for their patience.

"The good news for long-term investors is that Pacific Biosciences does enough cash on hand to keep the company afloat until 2016," noted my Foolish colleague George Budwell. "And the company looks like it will need the time to find an appropriate niche market for the PacBio RS II system."

When you couple Pacific's decent financial health with Hunkapiller's big buy, the stock looks like a particularly enticing speculation.