Biotech Blunder Turned 20% Overnight Gain

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Sometimes even when things go wrong, they can still work out in your favor. When Exelixis (Nasdaq: EXEL  ) announced a delay in presenting the results of its phase 3 trial testing cabozantinib in patients with advanced medullary thyroid cancer, I proposed three possible reasons for the delay:

  • Patients taking cabozantinib are living longer than expected.
  • Patients taking placebo are living longer than expected.
  • Both.

Turns out none of them were the case -- at least not when looking at the median progression free survival, a measurement of how long it takes for the tumor to start growing again.

Exelixis was looking for an eight-month median progression free survival for the placebo arm and hoping for at least a 75% increase for patients taking cabozantinib, so at least 14 months. The results announced today pegged the median progression free survival at just 4.0 months for the placebo and 11.2 months for patients taking cabozantinib. Nearly tripling placebo's median progression free survival is a solid win for cabozantinib -- there's less than a 0.01% chance that it happened randomly -- but the results were still nowhere near what Exelixis expected.

The estimate being off shouldn't be a big surprise; the median survival estimate was just a guess. Exelixis tightened the enrollment criteria in the phase 3 trial to include only patients with progressing disease, so the earlier phase 1/2 trial, which included less severe patients, wasn't much help in estimating how long it would take for the more-advanced patients to progress.

Medians vs. averages
But then why did the trial take longer than expected if the median progression-free survival was actually shorter than the estimate? We'll have to head back to third-grade math to explain this one.

The median of a group of numbers is the one in the middle. Unlike an average -- where you add up all the numbers and divide by the number of members in the group -- the numbers at the extreme don't matter for a median. So the median of 11,12,13,14,15 is 13, but the median of 11,12,13,14,30 is also 13.

Exelixis only released top-line data, but the simple explanation is that there are some patients in one or both of the groups that are outliers, taking a lot longer than the median to progress. Since the trial could only be stopped after a certain number of progression free survival events, the outliers delayed the readout even though they didn't affect the median.

Houston, do we have a problem?
If the outliers are predominately in the arm that got cabozantinib, there's likely a subset of patients that are responding well to cabozantinib, perhaps because their tumors have a genetic mutation that makes the cells more susceptible to killing by cabozantinib.

If you go back and look at the trial data for Bristol-Myers Squibb (NYSE: BMY  ) and Eli Lilly's (NYSE: LLY  ) Erbitux and Amgen's (Nasdaq: AMGN  ) Vectibix you'd find outliers on the other side -- those that didn't respond well to the treatment because they had a mutation in KRAS, which renders the drugs ineffective.

Having outliers in the cabozantinib arm is an interesting scientific puzzle that I'm sure Exelixis will follow up on, but it shouldn't affect the approval. Both Erbitux and Vectibix were approved, and then their labels were subsequently changed when the scientific discovery was made.

If the outliers are in the placebo group only, that could potentially spell trouble for an approval.

Placebo controlled trials are only accurate if the patients are evenly balanced between the two groups. Things like age and gender have to be controlled for in each trial, and then there are factors for each disease. Diabetes drug makers like MannKind (Nasdaq: MNKD  ) and Amylin Pharmaceuticals (Nasdaq: AMLN  ) for instance, have to match up the HbA1c levels to ensure there are similar HbA1c levels across the treatment groups.

The Food and Drug Administration could argue that having outliers only in the placebo group implies that the trial wasn't balanced. Of course the outliers landing in just the placebo group could have happened randomly as well, but then we're getting well beyond third-grade math.

Until we see the full data it's hard to handicap the risk of the FDA might balk, but I'd guess it's fairly low. First, there's a good chance that it can be explained by a response to cabozantinib, but even if the outliers were only in the placebo arm, it may not be the end of the world. There aren't any drugs approved to treat medullary thyroid cancer patients this late in progression -- AstraZeneca's (NYSE: AZN  ) vandetanib is approved for earlier use -- and the FDA tends to be more lenient with drugs for unmet medical needs.

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Important Steps Before Bankruptcy

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One of the most important time frames in the bankruptcy process is the time between the decision to file and actually filing the paperwork. Why? Because this is the time that you have to make several important steps, which can maximize your chances of a successful case. In fact, there are several very important steps that should be completed long before you even sign the bankruptcy petition.

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Improve Your Financial Situation With Debt Counselling

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Managing and budgeting your finances can be just straight up daunting and a nightmare. It always seems like more is going out than what's trickling in when it comes to money. As with anything though, and though it's hard to admit, there's always somebody who can manage things more efficiently than you can and that's why there are debt counsellors.

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Here Are The Best iPhone And iPad Apps You Missed This Week (AAPL)


soundcloud app

We've put together a list of all the best apps you missed this week for your iPhone and iPad.

This week, we have some great new iPad app versions of some of our favorites like Bloomberg, Mint, and Soundcloud, as well as some hot new games in the mix.

Mint's one of the best iPhone apps, and now there's an iPad app.

Mint is one of the most used apps on our iPhone because it, somehow, makes managing money and checking on your accounts fun and beautiful.

The iPad app is no different, offering a variety of charts, graphics, and tools to help you manage your money.

Price: free

Finally, there's a Bloomberg TV app for iPad.

With the new Bloomberg TV app, you can watch Bloomberg 24 hours a day, share content with friends via Facebook and Twitter, and even download videos for offline watching.

If you're in finance and have an iPad, this one's a can't-miss.

Price: free

SoundCloud's new iPad app is for music buffs.

SoundCloud is the way independent musicians share music online, and now there's an iPad app to help with the sharing, recording, and listening.

Straight from the app, you can even post songs to your Tumblr.

Price: free

See the rest of the story at Business Insider

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Source: http://feedproxy.google.com/~r/businessinsider/~3/ACF43zleZmA/best-iphone-ipad-apps-2011-10-28

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These 2012 Tax Law Changes Will Affect Your 401(k) And Your IRA


savings, piggy bank

The IRS just announced four tax changes for 2012 that will affect your retirement plans... And this time it's good news.

In case you haven't noticed what your wallet has been trying to tell you, the cost of living has been rising lately.

According to the Bureau of Labor Statistics, the consumer price index (CPI) has risen 3.9% over the past 12 months.

The price of energy (including gasoline) alone has increased by nearly 20%, and food prices have gone up 6% over the past year as well.

Fortunately, the rise in the cost of living has increased enough for the the IRS to take notice.

##Because they are required to make tax rule adjustments that keep up with inflation, the IRS has announced that they will increase certain retirement plan contribution limits and slightly relax income limit restrictions.

The adjustments will allow higher income workers to contribute to popular retirement plans such as IRAs and Roth IRAs. 

So why should you care?

Thanks to income-limit increases on a number of tax-sheltered retirement accounts, you may suddenly be eligible for tax breaks and receive tax credits that could significantly cut your tax bills.

In addition, the 2012 changes will allow all workers to contribute more towards retirement through their 401(k) plan. 

Also under these changes: If you're a worker with a low to moderate income, you may now become eligible to claim the saver's credit when you file your 2012 return.

The IRS has recently announced the following changes affecting 2012 tax-year retirement plans:

1. You May Contribute More to Your 401(k) Plan or other Employer-Sponsored Plan

The IRS has increased the amount you may contribute towards your 401(k) plan:

  • For the 2012 tax year, workers may contribute up to $17,000 ($500 more than in 2011) into their 401(k) plan, 403(b) plan, 457 plan or Thrift Savings Plan. 

  • If you're over age 50, you'll be able to contribute up to $22,500 into your employer-sponsored retirement plan (Note: The Catch-Up Contribution Limit of $5,500 remains unchanged for 2012).

Remember, every dollar you contribute into your 401(k) or other employer-sponsored plan (other than Roth plans) is tax-deductible. The more dollars you contribute, the smaller your tax bill will be.

It's a difficult feat for most, but if you could possibly manage to sock away $17,000 every year starting in 2012 (That's about $1,417 a month), you could grow your nest egg balance to $99,000 in 5 years, or $655,000 in 20 years -- assuming a 6% annual return.

[Have an old 401(k) sitting with a previous employer? Roll Over Your 401(k) Plan in 5 Easy Steps]

2. The IRA Income Limit Restrictions Have Been Loosened for 2012

While anyone can contribute to their own IRA, only workers who earn below a certain income level may receive a tax break (i.e. tax deduction) for each dollar they contribute. Next year, the income limit cap will be increased by $2,000, so people making more money will now be eligible for the tax-deductible contributions.

  • If you earn a modified adjusted gross income (AGI) that is under $58,000 ($92,000 for married couples) for 2012, you'll be eligible to get a tax-deduction for every dollar you contribute (up to the existing annual contribution limit of $5,000 or $6,000 for those over age 50) into an IRA. 

  • The IRA tax-deduction phases out for those who earn a modified AGI between $58,000 and $68,000 ($92,000 to $112,000 for married couples). 

  • If you're a married couple that is filing jointly, but only one of you has an employer-sponsored plan, the IRS has increased the modified AGI limit for full tax-deduction eligibility to $173,000. This tax-deduction phases out for those who earn a modified AGI between $173,000 and $183,000. Note: These income limit caps have been increased by $4,000 over the 2011 tax year.  

[InvestingAnswers Feature: The Pros and Cons of IRAs and 401(k)s]

3. Roth IRA Income Limit Restrictions Have Also Been Relaxed for 2012

The Roth IRA, a popular retirement account that offers tax-free withdrawals after age 59 ½, will see a slight change in eligibility rules as well. The IRS is raising the income caps on Roth IRAs, allowing higher income earners to contribute to the plan. The 2012 income cap will be $3,000 higher for single and head-of-household filers, and $4,000 higher for married couples filing jointly. 

  • For 2012, you'll be able to contribute to a Roth IRA if you earn a modified AGI below $110,000 ($173,000 for married couples). 

  • If you earn a modified AGI between $110,000 and $125,000 ($173,000 to $183,000 for married couples), you'll still be able to contribute to a Roth IRA; however, the amount you'll be able to contribute annually is more limited (i.e. phased out).    

[InvestingAnswers Feature: Traditional Vs. Roth: Which IRA is Right for You?

4. Eligibility for Saver's Credit Has Been Expanded

The income limit restrictions to be eligible for saver's credit have been loosened as well for 2012.

##The income limit cap has been raised by $500 for single filers, $750 for head of household filers and $1,000 for married couples over 2011's limits.

Like the other income limit cap increases, this change will allow more workers with higher incomes to claim this popular tax credit.

The saver's credit -- also known as the retirement savings contributions credit -- rewards low income or moderate income workers who are contributing towards their retirement plan.

If you're eligible for the saver's credit, you can receive a tax credit up to $1,000 ($2,000 for joint filers) depending on the amount you contribute towards a 401(k) plan, IRA, Roth IRA or other retirement plan.

  • You may claim the saver's credit if you contribute toward a retirement account and your modified AGI is below $28,750 (or $57,500 for married couples) for the 2012 tax year. 

  • The modified AGI limit for head of household filers is now $45,125; so if you qualify as head of household and make below that amount, you too may claim this rewarding tax credit.

The Investing Answer: 2012 is just around the corner, so keep these income limits and contribution limits in mind when tax planning next year. Whether you'll be eligible after these changes or if you've always been eligible to contribute to an IRA, Roth IRA or 401(k) plan, be sure and take advantage of these tax-sheltered plans if you have the means to do so.

If you're worker who makes a low or moderate income, the saver's credit could be looked at as free money on the table. Similar to a company's 401(k) match, this credit rewards you for every dollar you put into a 401(k) plan, Roth IRA or IRA. If you earn less than the income limit shown earlier, and you can put $2,000 towards retirement, you could potentially receive up to a $1,000 tax credit (depending on your actual level of income); Take advantage of this credit if you can.

This post originally appeared at Investing Answers.

Here are three things to look out for with the change →

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The Debt Review Process Explained

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Are you in debt and you have been looking for ways to ease your worry? Maybe the calls and letters and possibly even visits from your creditors is getting too much and you can't sleep at night. If this is the case you might have heard about the debt review process and want to know more about it. A debt review is a process that anyone who is in debt and who earns an income can apply for via a debt counselling company. If the review is successful the applicant will be able to make a single payment each month to a Payment Distribution Agency who will then make payments to the individual's various creditors.

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Markets Rest After Steep Two-Day Climb

The market took a break Friday, and who can blame it after a strong two-day push triggered by relief over Europe. European officials were finally able to hammer out an agreement to combat the escalating sovereign debt crisis, and the market responded positively. With so many fund managers lagging benchmarks for the year, the feeling now seems to be that the market still has some upside in store into year end.

Source: http://www.forbes.com/sites/greatspeculations/2011/10/28/markets-rest-after-steep-two-day-climb/

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Debt Relief Solutions For Your Debt Situation

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Bills have a way of piling up on almost everyone at some point in their lives. With the economy not being like it used to be, it may be unsettling to even begin to tackle to money issues you have been facing. The first thought on many minds is to simply ignore the debt collectors altogether.

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7 Habits Of The Highly Effective Trader Named Paul Tudor Jones


paul tudor jones

There is no question that Paul Tudor Jones is legendary in the trading world.

The founder of Tudor Investment Corporation is worth $3.2 billion, according to Forbes. At the tender age of 32 in the late 1980s, he was already managing over $125 million.

But his most prominent feat is probably predicting the Black Monday stock market crash of 1987, and tripling his fortune in a day by shorting stocks.

There's video proof of him predicting it - on the documentary PBS filmed about him called "Trader: The Documentary." Unfortunately, Jones had a change of heart after the piece was filmed, and wanted it out of circulation (maybe he bought up all the copies?). It's now extremely rare and hard to find- with the VHS going for up to $155 on eBay and hoarded by traders who watch it in hopes of extracting trading tips.

But fortunately for us, we found a highly detailed summary of the documentary at Order Flow Forex, and gleaned some of Jones' quirky and serious habits while he trades.

Trading at odd hours.

Jones wants to catch volatility in other markets, so he'll wake up at 4 a.m. to trade gold in Hong Kong, or trade forex on a Sunday in New Zealand.

Even when he was on vacation in Switzerland, Jones traded.

Source: Order Flow Forex

Using the Godzilla

Jones likes to a place a Godzilla toy above his trading computers to ward off the bears.

Source: Order Flow Forex

Looking for volatility

Jones looks for and predicts volatility in certain markets in order to make a profit. If he can predict a trend and ride it, then it'll pay off big time. In the documentary, Jones trades Deutsche Marks and crude oil based on what he believes will happen to the markets in lieu of recent news events (an OPEC announcement) and a hunch.

Source: Order Flow Forex

See the rest of the story at Business Insider

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Source: http://feedproxy.google.com/~r/businessinsider/~3/-46-j6gXTuU/paul-tudor-jones-trader-documentary-2011-10

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