DIRECTIONS: Read the following and answer the questions?
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For two decades, researchers hoped it might be possible to create a vaccine that teaches the body’s sentries, called dendritic cells, to recognize cancer, and then spur the immune system’s infantry, the T-cells, to attack the tumor. But every drug company that tried the approach failed — until last year. That’s when Seattle-based Dendreon got approval from the Food and Drug Administration to market its vaccine, Provenge, as a treatment for prostate cancer that has spread but is not causing symptoms like bone pain.
Matt Herper: How is it that you came to Dendreon? You already knew the company’s chief executive.
David Urdal: I was first approached by the man who was to become the CEO, Chris Henney, in 1994, and he asked me to look at this opportunity. Ev I was in post-doctoral fellowship in [Henney's] lab at the Fred Hutchinson Cancer Center. This was the late ’70s. That was when he and [Steve] Gillis founded Immunex Corporation and he recruited me to Immunex back in 1980-81 or whenever that was. And so I started working at Immunex as a scientist.
Matt Herper: Before Chris Henney was involved, Dendreon had been founded by two Stanford researchers, and had gone through a rough patch. What made the opportunity interesting to you?
David Urdal: Their names were Ed Engleman and Sam Strober, and the technology that was of particular interest to me and ultimately to Chris was the work that Ed Engleman was doing with the blood-derived dendritic cell, a type of immune cell. The company had originally been funded by Healthcare Ventures, and they had run through their first $10 million since founding two years earlier and Chris was faced with the challenge of the need to re-capitalize the company. We needed to put it on a path that would allow us to take the company public and have a more of a commercial focus.
The company initially had one piece of intellectual property and it was a device that could allow you to separate cells by buoyant density that was being applied at that time to the isolation of [blood] stem cells for stem cell transplantation. And Chris and I looked at that and go well geez, at that time we would have been the third of fourth company looking at stem cell isolation and transplantation.
But it was showing promise in these early first-in-human studies in cancer that Engleman was doing with Ron Levy. So we had a way of marrying the device that the company was working with a novel cell line that had the potential to really address some major unmet needs in cancer.
Matt Herper: And why did you choose prostate cancer? Other cancer vaccine companies focused on melanoma and blood cancers.
David Urdal: Well, two reasons really. The model that we were working in could find ways to induce immunity to the [prostate] gland. If we could do that consistently that we could potentially treat malignancies derived from that gland. And the second was just a back of the envelope opportunity analysis. It’s a huge unmet need. Prostate cancer is the second leading cause of cancer and mortality in men and we knew we’d have to spend hundreds of millions of dollars anyway. Might as well do it that setting as opposed to doing it in, I don’t know, one of the other cancers that at the time would have been more favored.
Matt Herper: Speeding forward a decade: Why did you decide to file for approval, FDA approval, that first time, given that the studies had missed their primary endpoints and that a third study, the IMPACT trial, was already going on?
Urdal: It was really the nature of the data and how strong the evidence was that we were actually having an impact on survival. We had a really important meeting with the FDA in 2005 at which we shared with them the survival results and the analyses that we’d done. We were really up front with them, we said, look we didn’t specify overall survival as a primary endpoint of the study but we followed every patient for three years and these are the results that we obtained. And all of the analysis, all of the analyses that we’d done, you know, we can’t another explanation for the outcome that we saw except that these men received [Provenge.]
The key outcome from that 2005 meeting was a very a clear: “We, the FDA, find the results provocative and we could do a review.” And we went out and we built out the first phase of the manufacturing plant in 2006 and completed our license application in 2006 and it was accepted for review in January 2007. Then we had our famous advisory committee meeting in 2007.
Matt Herper: That advisory committee voted that Provenge should be approved. But the FDA rejected it in May 2007. Were you surprised by that rejection?
David Urdal: Well, I thought the advisory committee went incredibly well for us. I mean it got all the data that reflected up to that time and we got an incredibly positive reception. We had a unanimous vote on safety.
Matt Herper: But there was a real split between the opinons of the oncologists, who had doubts, and the cell therapy folks, who were enthusiastic.
David Urdal: Of the four votes against approval at that time, two were members of the [Oncology Drugs Advisory Committee] that had been invited to participate in the meeting. And it was clear, when I look back on it now, that even though the vote came out in our favor, there also was a sentiment that was expressed during the course of that day where all parties found the results provocative but hoped that there would be a way that meaningful data could be obtained from the ongoing study, IMPACT, that everyone knew was still enrolling patients and would still have some follow-up period to go. And I think in the end that’s what drove the FDA making the decision that they did — that look, these results are compelling, but we don’t see that we can be assured that we’d get meaningful data that would support the efficacy claim if we were to approve it in 2007. And they might have been right.
But it wasn’t just them, I think if you follow the sentiments within the clinical community I think there was a sense of, okay, if it’s approved I’d probably prescribe it, but geez, it’s a small study, overall survival wasn’t the primary endpoint, there wasn’t a sense of enthusiasm for it, and I think in the end of course the IMPACT study results came back and this completely vindicated the results from the earlier trials.
Matt Herper: Why do you think it is that time to progression, the time it takes for the tumor to start growing, wasn’t affected by Provenge, but people lived longer? To a lot of people, that doesn’t make biological sense.
David Urdal: I think there are two things on progression that we learned in that study. Progression was occurring much more rapidly in asymptomatic population than we expected. Going into this, our key opinion leaders thought that in asymptomatic patients progression was occurring more slowly than it would it more symptomatic patients and we learned that that’s simply not true, they’re progressing in 12 to 14 weeks, which is just as quickly as they’re progressing later in the disease. The second thing that we learned is that we were not able to show an impact on time to disease progression in the way that we measured it, which was the time to the next progression event or two lesions in the bone. And so if the question is how can you have a drug that has an impact on survival but you don’t see an impact on progression, my belief would be that if we were measuring progression in a more continuous way you might expect to see an impact on the rate of progression. We just weren’t able to measure it.
Matt Herper: So you think the difference is in how the measurement was made, you don’t think it’s revealing differences in the biology?
Urdal: I think you’re asking a really key question. Because if you went too early you’d had to do a huge study. We are doing a study which is looking at men who have chosen to get a prostatectomy and they get Provenge some weeks in advance of that so that we can better understand the components in the immune system that are being engaged. But if you were to try to [receive FDA approval] it would have to be a huge study because 70 percent of the men are going to be cured with the surgery alone, and then you’d have to follow them for many many years before you could actually measure a clinical outcome. But we’re having with regulatory agencies in Europe and here in the United States about going into androgen-dependent prostate cancer that is metastatic at the time of diagnosis. The idea is and belief is that the earlier that we go the better the benefit.
Forbes: Last question: Why is the drug business in such a profound innovation drought? Why aren’t drug companies inventing more drugs?
Urdal: It’s something that I worry a lot about and from a slightly different point of view. Look at the dilemma that the venture capital community has. It’s a question of where does the capital come from to actually invest in the companies like the ones that I’ve been associated with. I don’t think there’s any way Immunex could go public today with the evidence it had to go public when it did, or Dendreon for that matter as we were starting our phase 3 program and went public. I think you need to be to the point of having complete clinical validation before you can expect an IPO to go out. So I think the dynamics have really changed. The horizon for VC funds is 10 years and the hurdle of having a body of data that you could go public on has only gotten higher. So where does the Dendreon come from, where does it get its capital? How do those early years get funded for the system to work?bara Ortutay, AP Technology Writer, On Wednesday August 3, 2011, 7:05 pm EDTNEW YORK (AP) -- Video game publisher Activision Blizzard Inc. said Wednesday that its second-quarter net income grew 53 percent, boosted by strong demand for digital offerings such as downloadable content for its popular "Call of Duty" games.
Activision earned $335 million, or 29 cents per share, in the April-June period. That's up 53 percent from $219 million, or 17 cents per share, in the same period a year earlier.
Revenue climbed 19 percent to $1.15 billion from $967 million.
On an adjusted basis Activision earned 10 cents per share, double what Wall Street expected. Adjusted revenue grew 2 percent to $699 million from $683 million last year. Analysts expected adjusted revenue of $601.9 million, according to FactSet.
The adjusted results exclude special items and account for the effects of deferring revenue and the related cost of sales for games with online components. Like other video game publishers, Activision spreads these out on its books over time, while the game is played, rather than all at once.
CEO Bobby Kotick called the quarter "phenomenal" and said Activision's focus continues to be investing in online services and its games' online capabilities. Of the company's total revenue, $423 million came from digital channels, such as monthly subscription fees for "World of Warcraft," downloadable content and games for mobile devices.
Activision's forecast for the current quarter fell shy of Wall Street's expectations, but the company raised its outlook for the full year. The fourth quarter is usually the most important one for video game companies because it includes holiday sales. Activision will launch the next version of its best-selling "Call of Duty" series in the fall.
The company now expects adjusted earnings for the year of 77 cents per share, up from its earlier outlook of 73 cents. Analysts predict 75 cents. Activision raised its 2011 adjusted revenue guidance to $4.05 billion from $3.95 billion. Analysts expect $4.06 billion.
Activision, based in Santa Monica, Calif., tends to give conservative guidance that it can later raise or beat. Its guidance for the current quarter is for adjusted earnings of a penny per share on revenue of $530 million. That's below Wall Street's estimates for 8 cents per share in earnings and $636.6 million in revenue.
The company said it has a very light game-release schedule in the current quarter compared with last year, when it launched blockbusters like "StarCraft 2" as well as a "Guitar Hero" and a "Spiderman" game. It only has one big game release, "X-Men: Destiny" in the third quarter of this year.
The fourth quarter, however, will be a big one for the company if all goes as planned. "Call of Duty: Modern Warfare 3" launches on Nov. 8, and Activision said pre-orders for the game are "significantly" higher than they were for its predecessor at this time. That game, "Call of Duty: Black Ops" broke entertainment industry records when it launched last year and made $1 billion in just six weeks in stores.
The company is also launching the full version of its online service for "Call of Duty," called "Call of Duty: Elite." The service, currently available in a "beta" test version, expands on what players already do online and helps them form groups, compete by skill level or share game stats. Eric Hirshberg, CEO of Activision Publishing, said in a conference call with analysts that "Elite" should "reset the bar" for multiplayer games.
Activision also has high hopes for "Skylanders: Spyro's Adventure," a game aimed mainly at boys aged 6 to 11 that combines real-life toys with online interactions. The game "truly defies categorization and creates an entirely new genre of play bringing the world of toys and video games of the Internet together like never before," Hirshberg said.
Shares rose 22 cents, or 1.9 percent, to $12.01 in after-hours trading. They closed 13 cents higher at $11.82 in the regular session. Because I worry a lot who’s going to be developing the drugs that are going to be of benefit for my granddaughter, they need to start now because it’s going to be 30 years down the road.
David Urdal: Of the four votes against approval at that time, two were members of the Oncology Drugs Advisory Committee] that had been invited to participate in the meeting. And it was clear, when I look?
A. TRUE
B. FALSE
Immunex could go public today with the evidence it had to go public when it did, or Dendreon for that matter as we were starting our phase 3 program and went public?
A. TRUE
B. FALSE
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For two decades, researchers hoped it might be possible to create a vaccine that teaches the body’s sentries, called dendritic cells, to recognize cancer, and then spur the immune system’s infantry, the T-cells, to attack the tumor. But every drug company that tried the approach failed — until last year. That’s when Seattle-based Dendreon got approval from the Food and Drug Administration to market its vaccine, Provenge, as a treatment for prostate cancer that has spread but is not causing symptoms like bone pain.
David Urdal, who served at Dendreon’s chief scientific officer for 16 years, is one of the key figures in that victory. Before Dendreon, he was head of manufacturing at Immunex, the pioneering Seattle biotech firm that was bought by Amgen for $16 billion in 2001. With Provenge having finally reached patients and with the company beginning to overcome the manufacturing challenges that have limited its sales, Urdal recently announced his decision to retire.
I sat down with Urdal to talk about how Provenge got to market – and about his hopes for the future of medicine. Points of interest: Urdal started working with Dendreon’s former chief executive, Chris Henney, shortly after getting his PhD.; he says the FDA might have made the right decision by rejecting Provenge in 2007, and later approving it; and he worries that biotech is getting too risky for venture capitalists. This interview has been edited for length and clarity.Matt Herper: How is it that you came to Dendreon? You already knew the company’s chief executive.
David Urdal: I was first approached by the man who was to become the CEO, Chris Henney, in 1994, and he asked me to look at this opportunity. Ev I was in post-doctoral fellowship in [Henney's] lab at the Fred Hutchinson Cancer Center. This was the late ’70s. That was when he and [Steve] Gillis founded Immunex Corporation and he recruited me to Immunex back in 1980-81 or whenever that was. And so I started working at Immunex as a scientist.
Matt Herper: Before Chris Henney was involved, Dendreon had been founded by two Stanford researchers, and had gone through a rough patch. What made the opportunity interesting to you?
David Urdal: Their names were Ed Engleman and Sam Strober, and the technology that was of particular interest to me and ultimately to Chris was the work that Ed Engleman was doing with the blood-derived dendritic cell, a type of immune cell. The company had originally been funded by Healthcare Ventures, and they had run through their first $10 million since founding two years earlier and Chris was faced with the challenge of the need to re-capitalize the company. We needed to put it on a path that would allow us to take the company public and have a more of a commercial focus.
The company initially had one piece of intellectual property and it was a device that could allow you to separate cells by buoyant density that was being applied at that time to the isolation of [blood] stem cells for stem cell transplantation. And Chris and I looked at that and go well geez, at that time we would have been the third of fourth company looking at stem cell isolation and transplantation.
But it was showing promise in these early first-in-human studies in cancer that Engleman was doing with Ron Levy. So we had a way of marrying the device that the company was working with a novel cell line that had the potential to really address some major unmet needs in cancer.
Matt Herper: And why did you choose prostate cancer? Other cancer vaccine companies focused on melanoma and blood cancers.
David Urdal: Well, two reasons really. The model that we were working in could find ways to induce immunity to the [prostate] gland. If we could do that consistently that we could potentially treat malignancies derived from that gland. And the second was just a back of the envelope opportunity analysis. It’s a huge unmet need. Prostate cancer is the second leading cause of cancer and mortality in men and we knew we’d have to spend hundreds of millions of dollars anyway. Might as well do it that setting as opposed to doing it in, I don’t know, one of the other cancers that at the time would have been more favored.
Matt Herper: Speeding forward a decade: Why did you decide to file for approval, FDA approval, that first time, given that the studies had missed their primary endpoints and that a third study, the IMPACT trial, was already going on?
Urdal: It was really the nature of the data and how strong the evidence was that we were actually having an impact on survival. We had a really important meeting with the FDA in 2005 at which we shared with them the survival results and the analyses that we’d done. We were really up front with them, we said, look we didn’t specify overall survival as a primary endpoint of the study but we followed every patient for three years and these are the results that we obtained. And all of the analysis, all of the analyses that we’d done, you know, we can’t another explanation for the outcome that we saw except that these men received [Provenge.]
The key outcome from that 2005 meeting was a very a clear: “We, the FDA, find the results provocative and we could do a review.” And we went out and we built out the first phase of the manufacturing plant in 2006 and completed our license application in 2006 and it was accepted for review in January 2007. Then we had our famous advisory committee meeting in 2007.
Matt Herper: That advisory committee voted that Provenge should be approved. But the FDA rejected it in May 2007. Were you surprised by that rejection?
David Urdal: Well, I thought the advisory committee went incredibly well for us. I mean it got all the data that reflected up to that time and we got an incredibly positive reception. We had a unanimous vote on safety.
Matt Herper: But there was a real split between the opinons of the oncologists, who had doubts, and the cell therapy folks, who were enthusiastic.
David Urdal: Of the four votes against approval at that time, two were members of the [Oncology Drugs Advisory Committee] that had been invited to participate in the meeting. And it was clear, when I look back on it now, that even though the vote came out in our favor, there also was a sentiment that was expressed during the course of that day where all parties found the results provocative but hoped that there would be a way that meaningful data could be obtained from the ongoing study, IMPACT, that everyone knew was still enrolling patients and would still have some follow-up period to go. And I think in the end that’s what drove the FDA making the decision that they did — that look, these results are compelling, but we don’t see that we can be assured that we’d get meaningful data that would support the efficacy claim if we were to approve it in 2007. And they might have been right.
But it wasn’t just them, I think if you follow the sentiments within the clinical community I think there was a sense of, okay, if it’s approved I’d probably prescribe it, but geez, it’s a small study, overall survival wasn’t the primary endpoint, there wasn’t a sense of enthusiasm for it, and I think in the end of course the IMPACT study results came back and this completely vindicated the results from the earlier trials.
Matt Herper: Why do you think it is that time to progression, the time it takes for the tumor to start growing, wasn’t affected by Provenge, but people lived longer? To a lot of people, that doesn’t make biological sense.
David Urdal: I think there are two things on progression that we learned in that study. Progression was occurring much more rapidly in asymptomatic population than we expected. Going into this, our key opinion leaders thought that in asymptomatic patients progression was occurring more slowly than it would it more symptomatic patients and we learned that that’s simply not true, they’re progressing in 12 to 14 weeks, which is just as quickly as they’re progressing later in the disease. The second thing that we learned is that we were not able to show an impact on time to disease progression in the way that we measured it, which was the time to the next progression event or two lesions in the bone. And so if the question is how can you have a drug that has an impact on survival but you don’t see an impact on progression, my belief would be that if we were measuring progression in a more continuous way you might expect to see an impact on the rate of progression. We just weren’t able to measure it.
Matt Herper: So you think the difference is in how the measurement was made, you don’t think it’s revealing differences in the biology?
David Urdal: No. I think you’re seeing support for that idea come out of the other immunotherapies in the last year or so, Prostvac when that was published last summer, same thing, and then ipilimumab [Yervoy, from Bristol-Myers Squibb]. You’re seeing drugs that are being described as having a delayed effect, and meanwhile you’ve got the cancer that continues to progress. So if you’re looking at time to next progression event you might not have a window of time long enough to have an impact on that particular measurement.
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Stocks rose slightly on Wednesday to snap an eight-day string of declines that sent prices down nearly 7 percent.
That stumble complicates matters for investors who recently pulled cash from the market, fearing a government default was a strong possibility. With that worry behind, the question is what to do next.
Richard Shortt had expected to be buying stocks, putting his sidelined money back to work. Yet he was at his home computer Wednesday, selling some of his stocks, and trimming investments in stock mutual funds. The 66-year-old from Somerville, Mass. put the proceeds into safer money-market mutual funds -- the same actions he took last week, when he sold stocks before Congress and President Obama reached the debt ceiling deal.
Shortt kept selling because he worries there's a growing risk that the economy will slip back into recession. He notes the debt deal emphasizes spending cuts, without revenue increases, or stimulus spending that he believes is needed to create jobs.
"It just doesn't seem like a formula for very happy times, for a long, long time," says Shortt, a semi-retired small business consultant. "I'm preparing for a long downturn, but leaving options open, to see if things do change."
President Obama's spokesman said Wednesday that the administration doesn't believe there's a risk that the economy will head back into a recession.
But investors like Shortt have become more cautious in response to troubling news, such as Tuesday's report that consumers cut spending in June for the first time in nearly two years. A weak manufacturing report came out a day earlier, and the government last week said the economy's growth in the first half of this year was the weakest since the recession ended in June 2009. Another influential report is due Friday, when the government will release its employment data for July, which will include the unemployment rate and number of jobs created.
Yet some sense an opportunity. The market research firm Birinyi Associates on Wednesday said that market indicators it tracks suggest stock prices could be set to rebound. Birinyi said too many investors have left prematurely, which creates an opportunity for buyers.
Still, many are anxious:
--Stocks: The Dow Jones industrial average on Wednesday finished up 0.3 percent. But it was down most of the day, which put the market at risk of posting its longest losing streak since 1978, the last time there were nine daily declines in a row.
After the recent losses, a broader stock index, the Standard & Poor's 500, is almost exactly where it started the year.
Investors withdrew a net of nearly $8.8 billion from stock mutual funds during the week that ended last Wednesday, according to the Investment Company Institute. Investors also pulled money from international stocks funds, withdrawing a net $1.3 billion.
--Gold: Prices hit a new record on Wednesday, not adjusted for inflation, topping $1,670 an ounce. Gold prices have risen nearly 13 percent since July 1, and have steadily risen since the start of 2009, when an ounce of gold sold for $880.
Investors believe gold is safe because it tends to hold its value when stocks are falling, and often rises when the dollar falls in value against other currencies, as it did Wednesday.
HSBC precious metals analyst James Steel said in a report that gold's continued rise after the debt deal was reached indicates the rally "is clearly supported by more than just the long drawn-out political arguments over the debt ceiling."
--Treasurys: Prices for Treasury bonds have been rising since the debt deal concluded, reflecting greater investor demand for the government IOUs. Their reputation as a safe haven has been renewed now that the government avoided a default. Treasury yields move opposite their prices. On Wednesday, the yield on the 10-year Treasury slipped as low as 2.56 percent, its lowest level since November. That's even though Moody's Investors Service assigned a negative outlook to U.S. debt, but confirmed its AAA rating, for now.
--Money-market mutual funds: Investors had been withdrawing huge sums from these investments a few days ago, but reversed course once the debt ceiling deal was signed into law. Money funds are typically safe places to stash cash, because they invest in only the safest forms of debt securities. But many money funds invest in Treasurys, a fact not lost on investors who withdrew money as the debt ceiling talks stalled. Nearly $122 billion was withdrawn from money funds in the seven-day period that ended Monday, a surge that cut the $2.6 trillion that the funds hold by almost 5 percent, according to Crane Data. But there was a shift on Tuesday with the debt deal's conclusion, with a net $6 billion flowing back in. That new cash suggests investors once again see money funds as safe.
--Volatility: The stock market's fear gauge, formally known as the Chicago Board of Options Exchange's Volatility Index, has risen to levels last seen in August 2010. The VIX, as market pros call it, is up 35 percent over the past eight trading days. In an unusually volatile market, investors are willing to pay hefty premiums for options that offer protection from price swings of stocks in the Standard & Poor's 500 index.
The recent return of volatility worries Harvey Rowen. He's trying to figure out when to shift more money into stocks on behalf of individual investors whose portfolios he manages as CEO of San Francisco-based Starmont Asset Management.
About 80 percent of the clients that Rowen's firm contacted during the debt ceiling debate chose to sell a portion of their stock holdings and leave the money in cash. But Rowen was reluctant Wednesday to move that money back into the market, noting that negative economic reports have offset positive news from the debt deal.
He's considering adding more alternative investments to the portfolios, such as gold and other commodities, but worries they carry big risks as well.
"It's a hard question now what to do," says Rowen. "It's a struggle to find investments that are prudent, and will give our clients a reasonable return....So for now, we're sitting on that cash."
Matt Herper: It’s seems that one aspect therapies is that you would, in theory, really want to use them early in the disease, when tumors are weaker and patients have stronger immune systems. But I don’t know how you do that in prostate cancer. The studies would need to be too big.Related Quotes
| Symbol | Price | Change |
|---|---|---|
| MCO | 35.63 | +1.31 |
| | ||
, On Wednesday August 3, 2011, 5:44 pm EDT
BOSTON (AP) -- What relief rally? Hope that the stock market would surge on news of Washington's debt ceiling deal has given way to pessimism. Increasingly defensive-minded investors are adapting to the reality that the economic recovery is stalling, if not ending.Stocks rose slightly on Wednesday to snap an eight-day string of declines that sent prices down nearly 7 percent.
That stumble complicates matters for investors who recently pulled cash from the market, fearing a government default was a strong possibility. With that worry behind, the question is what to do next.
Richard Shortt had expected to be buying stocks, putting his sidelined money back to work. Yet he was at his home computer Wednesday, selling some of his stocks, and trimming investments in stock mutual funds. The 66-year-old from Somerville, Mass. put the proceeds into safer money-market mutual funds -- the same actions he took last week, when he sold stocks before Congress and President Obama reached the debt ceiling deal.
Shortt kept selling because he worries there's a growing risk that the economy will slip back into recession. He notes the debt deal emphasizes spending cuts, without revenue increases, or stimulus spending that he believes is needed to create jobs.
"It just doesn't seem like a formula for very happy times, for a long, long time," says Shortt, a semi-retired small business consultant. "I'm preparing for a long downturn, but leaving options open, to see if things do change."
President Obama's spokesman said Wednesday that the administration doesn't believe there's a risk that the economy will head back into a recession.
But investors like Shortt have become more cautious in response to troubling news, such as Tuesday's report that consumers cut spending in June for the first time in nearly two years. A weak manufacturing report came out a day earlier, and the government last week said the economy's growth in the first half of this year was the weakest since the recession ended in June 2009. Another influential report is due Friday, when the government will release its employment data for July, which will include the unemployment rate and number of jobs created.
Yet some sense an opportunity. The market research firm Birinyi Associates on Wednesday said that market indicators it tracks suggest stock prices could be set to rebound. Birinyi said too many investors have left prematurely, which creates an opportunity for buyers.
Still, many are anxious:
--Stocks: The Dow Jones industrial average on Wednesday finished up 0.3 percent. But it was down most of the day, which put the market at risk of posting its longest losing streak since 1978, the last time there were nine daily declines in a row.
After the recent losses, a broader stock index, the Standard & Poor's 500, is almost exactly where it started the year.
Investors withdrew a net of nearly $8.8 billion from stock mutual funds during the week that ended last Wednesday, according to the Investment Company Institute. Investors also pulled money from international stocks funds, withdrawing a net $1.3 billion.
--Gold: Prices hit a new record on Wednesday, not adjusted for inflation, topping $1,670 an ounce. Gold prices have risen nearly 13 percent since July 1, and have steadily risen since the start of 2009, when an ounce of gold sold for $880.
Investors believe gold is safe because it tends to hold its value when stocks are falling, and often rises when the dollar falls in value against other currencies, as it did Wednesday.
HSBC precious metals analyst James Steel said in a report that gold's continued rise after the debt deal was reached indicates the rally "is clearly supported by more than just the long drawn-out political arguments over the debt ceiling."
--Treasurys: Prices for Treasury bonds have been rising since the debt deal concluded, reflecting greater investor demand for the government IOUs. Their reputation as a safe haven has been renewed now that the government avoided a default. Treasury yields move opposite their prices. On Wednesday, the yield on the 10-year Treasury slipped as low as 2.56 percent, its lowest level since November. That's even though Moody's Investors Service assigned a negative outlook to U.S. debt, but confirmed its AAA rating, for now.
--Money-market mutual funds: Investors had been withdrawing huge sums from these investments a few days ago, but reversed course once the debt ceiling deal was signed into law. Money funds are typically safe places to stash cash, because they invest in only the safest forms of debt securities. But many money funds invest in Treasurys, a fact not lost on investors who withdrew money as the debt ceiling talks stalled. Nearly $122 billion was withdrawn from money funds in the seven-day period that ended Monday, a surge that cut the $2.6 trillion that the funds hold by almost 5 percent, according to Crane Data. But there was a shift on Tuesday with the debt deal's conclusion, with a net $6 billion flowing back in. That new cash suggests investors once again see money funds as safe.
--Volatility: The stock market's fear gauge, formally known as the Chicago Board of Options Exchange's Volatility Index, has risen to levels last seen in August 2010. The VIX, as market pros call it, is up 35 percent over the past eight trading days. In an unusually volatile market, investors are willing to pay hefty premiums for options that offer protection from price swings of stocks in the Standard & Poor's 500 index.
The recent return of volatility worries Harvey Rowen. He's trying to figure out when to shift more money into stocks on behalf of individual investors whose portfolios he manages as CEO of San Francisco-based Starmont Asset Management.
About 80 percent of the clients that Rowen's firm contacted during the debt ceiling debate chose to sell a portion of their stock holdings and leave the money in cash. But Rowen was reluctant Wednesday to move that money back into the market, noting that negative economic reports have offset positive news from the debt deal.
He's considering adding more alternative investments to the portfolios, such as gold and other commodities, but worries they carry big risks as well.
"It's a hard question now what to do," says Rowen. "It's a struggle to find investments that are prudent, and will give our clients a reasonable return....So for now, we're sitting on that cash."
Urdal: I think you’re asking a really key question. Because if you went too early you’d had to do a huge study. We are doing a study which is looking at men who have chosen to get a prostatectomy and they get Provenge some weeks in advance of that so that we can better understand the components in the immune system that are being engaged. But if you were to try to [receive FDA approval] it would have to be a huge study because 70 percent of the men are going to be cured with the surgery alone, and then you’d have to follow them for many many years before you could actually measure a clinical outcome. But we’re having with regulatory agencies in Europe and here in the United States about going into androgen-dependent prostate cancer that is metastatic at the time of diagnosis. The idea is and belief is that the earlier that we go the better the benefit.
Forbes: Last question: Why is the drug business in such a profound innovation drought? Why aren’t drug companies inventing more drugs?
Urdal: It’s something that I worry a lot about and from a slightly different point of view. Look at the dilemma that the venture capital community has. It’s a question of where does the capital come from to actually invest in the companies like the ones that I’ve been associated with. I don’t think there’s any way Immunex could go public today with the evidence it had to go public when it did, or Dendreon for that matter as we were starting our phase 3 program and went public. I think you need to be to the point of having complete clinical validation before you can expect an IPO to go out. So I think the dynamics have really changed. The horizon for VC funds is 10 years and the hurdle of having a body of data that you could go public on has only gotten higher. So where does the Dendreon come from, where does it get its capital? How do those early years get funded for the system to work?bara Ortutay, AP Technology Writer, On Wednesday August 3, 2011, 7:05 pm EDTNEW YORK (AP) -- Video game publisher Activision Blizzard Inc. said Wednesday that its second-quarter net income grew 53 percent, boosted by strong demand for digital offerings such as downloadable content for its popular "Call of Duty" games.
Activision earned $335 million, or 29 cents per share, in the April-June period. That's up 53 percent from $219 million, or 17 cents per share, in the same period a year earlier.
Revenue climbed 19 percent to $1.15 billion from $967 million.
On an adjusted basis Activision earned 10 cents per share, double what Wall Street expected. Adjusted revenue grew 2 percent to $699 million from $683 million last year. Analysts expected adjusted revenue of $601.9 million, according to FactSet.
The adjusted results exclude special items and account for the effects of deferring revenue and the related cost of sales for games with online components. Like other video game publishers, Activision spreads these out on its books over time, while the game is played, rather than all at once.
CEO Bobby Kotick called the quarter "phenomenal" and said Activision's focus continues to be investing in online services and its games' online capabilities. Of the company's total revenue, $423 million came from digital channels, such as monthly subscription fees for "World of Warcraft," downloadable content and games for mobile devices.
Activision's forecast for the current quarter fell shy of Wall Street's expectations, but the company raised its outlook for the full year. The fourth quarter is usually the most important one for video game companies because it includes holiday sales. Activision will launch the next version of its best-selling "Call of Duty" series in the fall.
The company now expects adjusted earnings for the year of 77 cents per share, up from its earlier outlook of 73 cents. Analysts predict 75 cents. Activision raised its 2011 adjusted revenue guidance to $4.05 billion from $3.95 billion. Analysts expect $4.06 billion.
Activision, based in Santa Monica, Calif., tends to give conservative guidance that it can later raise or beat. Its guidance for the current quarter is for adjusted earnings of a penny per share on revenue of $530 million. That's below Wall Street's estimates for 8 cents per share in earnings and $636.6 million in revenue.
The company said it has a very light game-release schedule in the current quarter compared with last year, when it launched blockbusters like "StarCraft 2" as well as a "Guitar Hero" and a "Spiderman" game. It only has one big game release, "X-Men: Destiny" in the third quarter of this year.
The fourth quarter, however, will be a big one for the company if all goes as planned. "Call of Duty: Modern Warfare 3" launches on Nov. 8, and Activision said pre-orders for the game are "significantly" higher than they were for its predecessor at this time. That game, "Call of Duty: Black Ops" broke entertainment industry records when it launched last year and made $1 billion in just six weeks in stores.
The company is also launching the full version of its online service for "Call of Duty," called "Call of Duty: Elite." The service, currently available in a "beta" test version, expands on what players already do online and helps them form groups, compete by skill level or share game stats. Eric Hirshberg, CEO of Activision Publishing, said in a conference call with analysts that "Elite" should "reset the bar" for multiplayer games.
Activision also has high hopes for "Skylanders: Spyro's Adventure," a game aimed mainly at boys aged 6 to 11 that combines real-life toys with online interactions. The game "truly defies categorization and creates an entirely new genre of play bringing the world of toys and video games of the Internet together like never before," Hirshberg said.
Shares rose 22 cents, or 1.9 percent, to $12.01 in after-hours trading. They closed 13 cents higher at $11.82 in the regular session. Because I worry a lot who’s going to be developing the drugs that are going to be of benefit for my granddaughter, they need to start now because it’s going to be 30 years down the road.
David Urdal: Of the four votes against approval at that time, two were members of the Oncology Drugs Advisory Committee] that had been invited to participate in the meeting. And it was clear, when I look?
A. TRUE
B. FALSE
Immunex could go public today with the evidence it had to go public when it did, or Dendreon for that matter as we were starting our phase 3 program and went public?
A. TRUE
B. FALSE
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