Friday 28/08/20 Gasto del consumidor

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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Vie Ago 28, 2020 12:56 pm

T CHG %CHG
DJIA 28588.10 95.83 0.34
S&P 500 3496.05 11.50 0.33
Nasdaq Composite 11673.07 47.73 0.41
Japan: Nikkei 225 22882.65 -326.21 -1.41
UK: FTSE 100 5963.57 -36.42 -0.61
Crude Oil Futures 42.94 -0.10 -0.23
Gold Futures 1972.40 39.80 2.06
Yen 105.47 -1.10 -1.03
Euro 1.1888 0.0066
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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Vie Ago 28, 2020 2:37 pm

LAST CHG %CHG
DJIA 28724.96 232.69 0.82
S&P 500 3507.86 23.31 0.67
Nasdaq Composite 11694.00 68.66 0.59
Japan: Nikkei 225 22882.65 -326.21 -1.41
UK: FTSE 100 5963.57 -36.42 -0.61
Crude Oil Futures 42.98 -0.06 -0.14
Gold Futures 1972.50 39.90 2.06
Yen 105.40 -1.17 -1.10
Euro 1.1898
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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Vie Ago 28, 2020 6:16 pm

Citigroup reports better-than-expected earnings on strong trading results
PUBLISHED TUE, JUL 14 20207:40 AM EDTUPDATED TUE, JUL 14 202010:57 AM EDT
Fred Imbert
@FOIMBERT
Here’s how Citigroup’s results compared to Wall Street expectations
Earnings: 50 cents per share vs 28 cents per share expected
Revenue: $19.77 billion vs $19.12 billion forecast
Fixed income, currency and commodities trading revenue: $5.6 billion vs $4.86 billion forecast
WATCH NOW
VIDEO01:49
How Citi’s Q2 earnings compare to JPMorgan’s, Wells Fargo’s results
Citigroup on Tuesday reported second-quarter results that surpassed analyst expectations thanks in part to a massive surge in trading revenue that helped offset a slowdown in the company’s consumer banking business.

Here’s how the company’s results compared to analyst estimates:

Earnings: 50 cents per share vs 28 cents per share expected by Refinitiv
Revenue: $19.77 billion vs $19.12 billion forecast
Fixed income, currency and commodities trading revenue: $5.6 billion vs $4.86 billion forecast by FactSet

The bank’s stock dipped more than 2% in morning trading, however.

Citigroup’s fixed income trading revenue represents a 68% year over-year surge and accounted for most of the company’s Markets and Securities Services revenues, which rose 48% to $6.9 billion.

Those elevated trading numbers come amid heightened market volatility during the coronavirus pandemic. They also come on the heels of massive monetary stimulus from the Federal Reserve. Equity trading revenue dipped 3% to $770 million, however.

Citigroup’s global consumer banking division struggled during the second quarter, with revenues falling 10% to $7.34 billion on a year-over-year basis. Net credit losses, meanwhile, jumped 12% year over year to $2.2 billion. Ultimately, the company posted net income of $1.32 billion, which represents a 73% drop from the second quarter of 2019.

“While credit costs weighed down our net income, our overall business performance was strong during the quarter, and we have been able to navigate the COVID-19 pandemic reasonably well. The Institutional Clients Group had an exceptional quarter, marked by an increase in Fixed Income of 68%,” CEO Michael Corbat said in a statement.

“With a sharp emphasis on risk management, we are prepared for a variety of scenarios and will continue to operate our institution prudently given this unprecedented situation,” Corbat added.

Citigroup shares are up nearly 12% the last three months through Monday’s close, outperforming peers such as JPMorgan Chase, Wells Fargo and Bank of America. JPMorgan and Bank of America were roughly flat in that time and Wells lost 19.2%. JPMorgan and Wells also reported earnings on Tuesday.

Citigroup announced in late June it would maintain its quarterly dividend after passing the Federal Reserve’s annual stress test.

Citigroup’s results Tuesday come in what is expected to be the one of the worst earnings season on Wall Street. Analysts polled by Refinitiv expect S&P 500 earnings to have fallen by 44% on a year-over-year basis.

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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Vie Ago 28, 2020 6:17 pm

LAST CHG %CHG
DJIA 28653.87 161.60 0.57
S&P 500 3508.01 23.46 0.67
Nasdaq Composite 11695.63 70.30 0.60
Japan: Nikkei 225 22882.65 -326.21 -1.41
UK: FTSE 100 5963.57 -36.42 -0.61
Crude Oil Futures 42.93 -0.11 -0.26
Gold Futures 1972.60 40.00 2.07
Yen 105.37 -1.20 -1.13
Euro 1.1906
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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Vie Ago 28, 2020 6:17 pm

LAST CHG %CHG
Crude Oil Futures 42.93 -0.11 -0.26
Brent Crude Futures 45.94 0.13 0.28
Gold Futures 1972.60 40.00 2.07
Silver Futures 27.605 0.580 2.15
DJIA Futures 28627 159 0.56
S&P 500 Futures 3506.75 21.45
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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Vie Ago 28, 2020 6:19 pm

Trump Administration Begins Payroll Tax Deferral Plan
Employers are wary of the tax postponement, which begins in September

By Updated Aug. 28, 2020 6:29 pm ET

The Treasury Department is offering its first guidance to employers on the Trump administration’s payroll tax deferral plan.
Photo: erik s lesser/Shutterstock
WASHINGTON—The Treasury Department began implementing President Trump’s plan to allow a payroll tax deferral, an executive action he says will help households weather the pandemic-ravaged economy but which faces significant practical hurdles and skepticism from employers.

The government’s announcement came late Friday, just four days before it is scheduled to take effect. It postpones some payroll taxes that would normally be due between Sept. 1 and Dec. 31 and makes them due between Jan. 1 and April 30, 2021. Under this approach, employers who opt to stop some paycheck withholding now could withhold twice as much as usual early next year.

Mr. Trump on Aug. 8 ordered the Treasury Department to allow the tax deferrals under a law that lets the Treasury secretary postpone tax deadlines after a disaster. It still could take time for private payroll companies to reprogram their systems, and employers concerned about costs and legal exposure may not bother changing workers’ tax withholding.

The president wants employers to stop withholding the 6.2% payroll tax that represents the employee’s share of Social Security taxes. The deferral would apply only to workers with annualized salaries below $104,000 and is intended to provide temporary assistance to households while lawmakers are deadlocked on a broader economic-relief bill.

The government’s action doesn’t actually change the underlying taxes, because only Congress can do that. Employees would still owe the taxes eventually. So someone making $75,000 annually could save as much as $1,550 in 2020 but would have to pay that same amount later.

Mr. Trump wants Congress to forgive that tax liability. The IRS document issued late Friday says employers must pay those taxes in the first four months of 2021 or “may make arrangements” to collect the taxes from employees.

“The guidance makes it clear the only purpose of this scheme is to give the illusion of a tax cut before the election,” said Seth Hanlon, senior fellow at the Center for American Progress, a group aligned with Democrats.

Implementation would be optional for employers, and larger employers have been wary about participating because they could also face potential tax liability, particularly for workers who leave their jobs and aren’t subject to withholding in early 2021.

The U.S. Chamber of Commerce, the National Council of Chain Restaurants and other trade associations warned that it would be unfair to impose potential future costs on workers and said a system where employees could choose whether to participate would be unworkable.

“Therefore, many of our members will likely decline to implement deferral, choosing instead to continue to withhold and remit to the government the payroll taxes required by law,” the groups wrote last week.

One very large employer looks likely to participate—the federal government that Mr. Trump controls. The National Finance Center at the Department of Agriculture, which processes payrolls for more than 600,000 federal workers at multiple agencies, said last week it was preparing to implement the tax deferral in September.

Forcing hundreds of thousands of federal employees to take tax deferrals could put pressure on lawmakers to forgive the taxes later, as Mr. Trump wants them to do.

“The Trump Administration’s plan to initiate payroll tax deferrals for civil servants treats the federal workforce as a guinea pig for a bad policy,” said Rep. Don Beyer (D., Va.), whose district includes many federal workers. “It is just another gimmick intended to give the appearance of action as the White House continues to stall negotiations for a real stimulus package.”

In an Aug. 21 memo first reported by Tax Notes, the Agriculture Department made no mention of giving workers a choice about whether to stop withholding. In a subsequent memo Friday, the department said it may change withholding and was awaiting further guidance from the Treasury and the Office of Personnel Management.

Among the agencies served by the National Finance Center is the IRS itself. Tony Reardon, president of the National Treasury Employees Union, which represents IRS workers, said employees should be given the ability to opt out of the deferrals.

Without a clear explanation, “we fear that too many employees will be unprepared for the higher tax obligation in 2021,” he said. “Additionally, we are especially concerned about IRS employees because an overdue tax debt can have severe job consequences.”

The General Services Administration, which provides payroll for other agencies, said it was waiting for guidance from the Treasury.
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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Vie Ago 28, 2020 6:21 pm

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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Sab Ago 29, 2020 1:24 pm

Market posts one of the strongest July-August rallies in history as hazard after hazard melts away
PUBLISHED SAT, AUG 29 20208:10 AM EDT
Michael Santoli
@MICHAELSANTOLI
The S&P 500 is up 13% since June 30, while rising the past seven days in a row and every day in August but four.
Persistent rallies that defy, say, the seasonal tendency for weakness in August and go on long win streaks are signs of underlying strength.
But the S&P 500 is more extended further above its 200-day average than at any time but one in the past decade. So no one should be surprised by a pause or sharp pullback for any reason or none at all.
Traders wearing masks work, on the first day of in person trading since the closure during the outbreak of the coronavirus disease
Traders wearing masks work, on the first day of in person trading since the closure during the outbreak of the coronavirus disease (COVID-19) on the floor at the New York Stock Exchange (NYSE) in New York, U.S., May 26, 2020.
Brendan McDermid | Reuters
This was the summer investors fell hard for risk — at first reluctantly, having just been dumped over the winter, and now avidly.

The embrace of stocks by those willing to take the chance in the spring has been blissful: The S&P 500 has gained 60% from the March 23 low and 13% since June 30, while rising the past seven days in a row and every day in August but four. Up more than 7% this month, it’s lining up to be the best August since 1984.



The approach of shorter days and cooler nights now prompts the question: Has it been too good to last without some hard adjustments?

Genuine Attraction

Submitting to the charms of risk assets was more than a fickle crush or opportunistic pairing. Following the shock of a mandated economic contraction, hazards melted away in ways both powerful and enduring.

The huge fast fiscal-spending push and limitless central-bank money provision not only short-circuited the recession and placed a higher floor on stocks and corporate credit. It provided a real-world experiment in government authorities’ vast spending powers, which no doubt will be demanded in future downturns.

Corporate profits have proved more resilient than feared, both because giant, secular-growth companies account for an outsize portion of S&P 500 earning power and because there has been no painful reckoning of massive bankruptcies.

Leuthold Group’s Jim Paulsen shows the apparent low point in S&P 500 profit margins this year is vastly higher than the troughs of prior recessions.



The economic retrenchment also reset the capital-labor relationship back in favor of capital, companies enjoying cheap financing at a time of ample supply of workers – we went from late-cycle margin pressures to early-cycle earnings leverage without the prolonged purge of a grinding recession – so far.

The Federal Reserve has made it clear as possible it will remain in emergency easy-money mode for years, most likely, allowing the economy and inflation run further in pursuit of full employment. This leaves the markets with a similar monetary backdrop to the start of the last expansion in 2009, but with less chance of something like the taper tantrum of 2013 or the close-call of a first interest-rate hike in 2015, which unsettled markets.

All of this helps explain the remarkable catapult-like rally from the intense panicky lows of March, and goes some distance to rebutting the idea of a stark disconnect between the markets and the still-hobbled economy being denied a fresh round of fiscal help.

Too Much Too Soon?

What’s not to like, then?

In broad terms, not too much. Persistent rallies that defy, say, the seasonal tendency for weakness in August and go on long win streaks — such as the S&P setting a record each day last week, or rising 80% of all days in a month — are signs of underlying strength. This type of behavior tends to come in strong bull markets, and typically not at the very end of them.

Much has been said about the erratic breadth readings, with more stocks down than up about half of all days in August even as the index has been rising. Yet the majority of stocks are broadly in uptrends and in fact, strength has broadened a bit toward cyclical groups in recent weeks, an answer to the complaint the rally was all about a handful of monster-cap growth stocks.

That said, the level of infatuation on display among traders toward at least some parts of the market now invites possible disappointment and disillusionment before too long.

In bull markets strength begets strength — up to a point. The S&P 500 is more extended further above its 200-day average than at any time but one in the past decade. The index’s relative strength index — a measure of momentum — pushed up to 80 Friday — pretty thin air. While, once again, a feature of sturdy bull markets, such readings mean no one should be surprised by a pause or sharp pullback for any reason or none at all.

Bespoke Investment Group, while underscoring the upbeat message of the tape, notes, “Issues that do pose headwinds of various intensity include the upcoming election, seasonality into September, and the recent underperformance of semis versus the broader market. This week, as the market was hitting record highs, the relative strength of semis versus the S&P 500 dropped to one-month lows.”

Ryan Detrick of LPL Financial notes the last two times stocks gained more than 5% in August (in 1986 and 2000), the S&P lost between 5% and 8% in September.

The speculative buying in call options, especially on the big, beloved tech stocks, has been voracious, driving the put/call ratio to lows not seen in a decade — usually a sign of over-bullishness and complacency in the short-term, though not a perfect contrarian signal. The bloated prices of call options have made strong stocks more volatile as they rise, an anomaly that reflects traders figuratively paying a premium to face value for lottery tickets.

The enormous surge in Apple and Tesla shares following their respective stock-split announcements — up between 30% and 60% in a few weeks — implies a lot of excitement over an insubstantial, mostly cosmetic move. Both stocks, for what it might be worth, popped higher early Friday before ending in the red, despite a broadly rising market, with the splits taking effect Monday.

Analysts have been hustling to boost share-price targets on high-momentum stocks, often using aggressive assumptions about growth rates and applying the valuations of the most richly valued peer companies to divisions of others.

Offsetting some of this aggressiveness are still-muted fund flows and the fact that Wall Street strategists’ average year-end S&P 500 price target is around 3200, more than 8% below where it closed Friday, hardly a sign that speculative froth is pervasive.

We’ve reached a tricky part of this rally, where standard bull-market behavior can also, in the lengthening light of a summer evening, be viewed as overheated recklessness.

Having some perspective on the scale of potential further upside relative to the risk of payback is the trick. Bank of America global strategist Michael Hartnett, spot on with his risk-on call for months now, says the ingredients aren’t yet there for a decisive market top.

He notes this rally would become the greatest ever in terms of speed and magnitude of gain if the S&P surpassed 3630 by Election Day. In other words, up another 3.5% over the next two months.

Is that appealing enough for smitten investors to stay committed to their summertime fling?
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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Sab Ago 29, 2020 1:24 pm

Market posts one of the strongest July-August rallies in history as hazard after hazard melts away
PUBLISHED SAT, AUG 29 20208:10 AM EDT
Michael Santoli
@MICHAELSANTOLI
The S&P 500 is up 13% since June 30, while rising the past seven days in a row and every day in August but four.
Persistent rallies that defy, say, the seasonal tendency for weakness in August and go on long win streaks are signs of underlying strength.
But the S&P 500 is more extended further above its 200-day average than at any time but one in the past decade. So no one should be surprised by a pause or sharp pullback for any reason or none at all.
Traders wearing masks work, on the first day of in person trading since the closure during the outbreak of the coronavirus disease
Traders wearing masks work, on the first day of in person trading since the closure during the outbreak of the coronavirus disease (COVID-19) on the floor at the New York Stock Exchange (NYSE) in New York, U.S., May 26, 2020.
Brendan McDermid | Reuters
This was the summer investors fell hard for risk — at first reluctantly, having just been dumped over the winter, and now avidly.

The embrace of stocks by those willing to take the chance in the spring has been blissful: The S&P 500 has gained 60% from the March 23 low and 13% since June 30, while rising the past seven days in a row and every day in August but four. Up more than 7% this month, it’s lining up to be the best August since 1984.



The approach of shorter days and cooler nights now prompts the question: Has it been too good to last without some hard adjustments?

Genuine Attraction

Submitting to the charms of risk assets was more than a fickle crush or opportunistic pairing. Following the shock of a mandated economic contraction, hazards melted away in ways both powerful and enduring.

The huge fast fiscal-spending push and limitless central-bank money provision not only short-circuited the recession and placed a higher floor on stocks and corporate credit. It provided a real-world experiment in government authorities’ vast spending powers, which no doubt will be demanded in future downturns.

Corporate profits have proved more resilient than feared, both because giant, secular-growth companies account for an outsize portion of S&P 500 earning power and because there has been no painful reckoning of massive bankruptcies.

Leuthold Group’s Jim Paulsen shows the apparent low point in S&P 500 profit margins this year is vastly higher than the troughs of prior recessions.



The economic retrenchment also reset the capital-labor relationship back in favor of capital, companies enjoying cheap financing at a time of ample supply of workers – we went from late-cycle margin pressures to early-cycle earnings leverage without the prolonged purge of a grinding recession – so far.

The Federal Reserve has made it clear as possible it will remain in emergency easy-money mode for years, most likely, allowing the economy and inflation run further in pursuit of full employment. This leaves the markets with a similar monetary backdrop to the start of the last expansion in 2009, but with less chance of something like the taper tantrum of 2013 or the close-call of a first interest-rate hike in 2015, which unsettled markets.

All of this helps explain the remarkable catapult-like rally from the intense panicky lows of March, and goes some distance to rebutting the idea of a stark disconnect between the markets and the still-hobbled economy being denied a fresh round of fiscal help.

Too Much Too Soon?

What’s not to like, then?

In broad terms, not too much. Persistent rallies that defy, say, the seasonal tendency for weakness in August and go on long win streaks — such as the S&P setting a record each day last week, or rising 80% of all days in a month — are signs of underlying strength. This type of behavior tends to come in strong bull markets, and typically not at the very end of them.

Much has been said about the erratic breadth readings, with more stocks down than up about half of all days in August even as the index has been rising. Yet the majority of stocks are broadly in uptrends and in fact, strength has broadened a bit toward cyclical groups in recent weeks, an answer to the complaint the rally was all about a handful of monster-cap growth stocks.

That said, the level of infatuation on display among traders toward at least some parts of the market now invites possible disappointment and disillusionment before too long.

In bull markets strength begets strength — up to a point. The S&P 500 is more extended further above its 200-day average than at any time but one in the past decade. The index’s relative strength index — a measure of momentum — pushed up to 80 Friday — pretty thin air. While, once again, a feature of sturdy bull markets, such readings mean no one should be surprised by a pause or sharp pullback for any reason or none at all.

Bespoke Investment Group, while underscoring the upbeat message of the tape, notes, “Issues that do pose headwinds of various intensity include the upcoming election, seasonality into September, and the recent underperformance of semis versus the broader market. This week, as the market was hitting record highs, the relative strength of semis versus the S&P 500 dropped to one-month lows.”

Ryan Detrick of LPL Financial notes the last two times stocks gained more than 5% in August (in 1986 and 2000), the S&P lost between 5% and 8% in September.

The speculative buying in call options, especially on the big, beloved tech stocks, has been voracious, driving the put/call ratio to lows not seen in a decade — usually a sign of over-bullishness and complacency in the short-term, though not a perfect contrarian signal. The bloated prices of call options have made strong stocks more volatile as they rise, an anomaly that reflects traders figuratively paying a premium to face value for lottery tickets.

The enormous surge in Apple and Tesla shares following their respective stock-split announcements — up between 30% and 60% in a few weeks — implies a lot of excitement over an insubstantial, mostly cosmetic move. Both stocks, for what it might be worth, popped higher early Friday before ending in the red, despite a broadly rising market, with the splits taking effect Monday.

Analysts have been hustling to boost share-price targets on high-momentum stocks, often using aggressive assumptions about growth rates and applying the valuations of the most richly valued peer companies to divisions of others.

Offsetting some of this aggressiveness are still-muted fund flows and the fact that Wall Street strategists’ average year-end S&P 500 price target is around 3200, more than 8% below where it closed Friday, hardly a sign that speculative froth is pervasive.

We’ve reached a tricky part of this rally, where standard bull-market behavior can also, in the lengthening light of a summer evening, be viewed as overheated recklessness.

Having some perspective on the scale of potential further upside relative to the risk of payback is the trick. Bank of America global strategist Michael Hartnett, spot on with his risk-on call for months now, says the ingredients aren’t yet there for a decisive market top.

He notes this rally would become the greatest ever in terms of speed and magnitude of gain if the S&P surpassed 3630 by Election Day. In other words, up another 3.5% over the next two months.

Is that appealing enough for smitten investors to stay committed to their summertime fling?
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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Sab Ago 29, 2020 1:25 pm

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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Sab Ago 29, 2020 1:26 pm

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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Sab Ago 29, 2020 1:27 pm

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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Dom Ago 30, 2020 5:26 pm

Stock futures rise as Wall Street wraps up its best August in more than 30 years
PUBLISHED SUN, AUG 30 20206:00 PM EDTUPDATED 24 MIN AGO
Fred Imbert
@FOIMBERT
Traders and financial professionals work ahead of the closing bell on the floor of the New York Stock Exchange.
Traders and financial professionals work ahead of the closing bell on the floor of the New York Stock Exchange.
Johannes Eisele | AFP | Getty Images
U.S. stock futures rose on Sunday night as traders were set to end the market’s best August performance since the 1980s.

Dow Jones Industrial Average futures were up 60 points, or 0.2%. S&P 500 and Nasdaq 100 futures gained 0.1% each.


The S&P 500 is up 7.2% month to date, putting the broader-market index on track for its biggest August gain since 1984. The Dow has rallied more than 8% this month and is also headed for its best August in 36 years.

This month’s gains have pushed the S&P 500 to record levels, officially confirming a new bull market has started. The Dow, meanwhile, erased its 2020 losses on Friday, closing the session with a year-to-date gain 0.4%.

The August rally built on the market’s sharp rebound off the March 23 intraday lows. Since then, the Dow and S&P 500 are up 57% and 60.1%, respectively.

We “had hoped that the market would consolidate its gains since March 23, giving earnings a chance to rebound,” said Ed Yardeni, president and chief investment strategist at Yardeni Research, in a note. “However, Fed officials continue to drive up stock prices by committing to keeping interest rates close to zero for a very long time … Consequently, they are fueling the meltup in stock prices.”

Earlier this year, the Federal Reserve cut rates to zero and launched an open-ended asset-purchasing program to support the economy through the coronavirus pandemic. Last week, the central bank laid out an inflation policy framework that would keep rates lower for longer.

New Dow look

The Dow will kick off the week with three new constituents and with Apple having a much smaller influence on the 30-stock average.

Come Monday’s open, Salesforce, Amgen and Honeywell will be included in the Dow, replacing longtime component Exxon Mobil, Pfizer and Raytheon Technologies. A 4-for-1 Apple stock split will also take effect on Monday.

Traders will also look ahead to Friday, when the latest U.S. jobs report is set for release. Economists polled by Dow Jones forecast that 1.255 million jobs were created in August.

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Re: Friday 28/08/20 Gasto del consumidor

Notapor admin » Dom Ago 30, 2020 5:28 pm

FDA willing to fast track coronavirus vaccine before phase three trials end
PUBLISHED SUN, AUG 30 202010:37 AM EDTUPDATED 6 HOURS AGO
Sarah O’Brien
@SARAHTGOBRIEN
FDA Commissioner Stephen Hahn said in an interview with the Financial Times that he’s willing to consider granting emergency authorization for a Covid-19 vaccine before clinical trials have been completed.
The comments come about a week after President Trump accused the FDA for intentionally moving slowly to hurt him politically.
Commissioner of U.S. Food and Drug Administration Dr. Stephen M. Hahn speaks during a news conference about the latest coronavirus disease (COVID-19) developments, in the Brady Press Briefing Room of the White House in Washington, U.S. August 23, 2020.
Commissioner of U.S. Food and Drug Administration Dr. Stephen M. Hahn speaks during a news conference about the latest coronavirus disease (COVID-19) developments, in the Brady Press Briefing Room of the White House in Washington, U.S. August 23, 2020.
Erin Scott | Reuters
The chief of the U.S. Food and Drug Administration is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible, according to an interview in The Financial Times.

Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.


“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told The Financial Times. “If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

The comments come a week after the FDA granted emergency authorization of convalescent plasma to treat hospitalized Covid-19 patients, despite concerns among some health officials that data from clinical trials is too weak to support widespread application of the treatment yet. That announcement was on the heels of President Trump accusing the FDA, without any evidence, of trying to hurt him politically by dragging its feet in approving new coronavirus vaccines and treatments.

Hahn told the Financial Times that he wouldn’t rush a vaccine solely to please Trump.

“We have a convergence of the Covid-19 pandemic with the political season, and we’re just going to have to get through that and stick to our core principles,” Hahn said.

“This is going to be a science, medicine, data decision,” he said. “This is not going to be a political decision.”


WATCH NOW
VIDEO03:52
Gottlieb: Vaccine for those at-risk could get emergency authorization before year-end
He said emergency authorization could be used to safely make the vaccine available for use by certain groups before clinical trials are completed.

“Our emergency use authorization is not the same as a full approval,” Hahn said. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”

Scott Gottlieb, former FDA chief, said Sunday on CBS’ “Face the Nation” that he’s uncertain what Hahn meant.

“I’m not sure what he means by approving it earlier than when the trials are completed,” Gottlieb said. “They are going to wait for these trials to read out before they can make a decision around the efficacy of these vaccines.”

He said it’s likely that data from phase three trials would come out in November. However, he said as the trials progress, if the results show the vaccine is very effective, that could be October.

Nevertheless, he expects the first approvals to be done on an emergency basis and targeted at groups that may be at more risk for infection or a bad outcome.

“A full approval for the general population — when people can go to CVS and get a shot — that’s really a 2021 event,” Gottlieb said.

Last week, The Financial Times reported that the Trump administration was considering an emergency use authorization before the presidential election for an experimental coronavirus vaccine developed in the U.K. by Oxford University and AstraZeneca.

At the time, a spokesperson for the Department of Health and Human Services, which includes the FDA, said any reports about an emergency authorization for a vaccine prior to the election were “absolutely false.” AstraZeneca said it had not discussed such a move with the U.S. government.

Already, China and Russia have each approved vaccines without waiting for the completion of phase three trials, which come with the most rigorous testing for a potential new drug. Public health officials in the U.S. and elsewhere have warned that the move could be unsafe.

The coronavirus has infected more than 5.9 million people in the U.S. as of Saturday, representing about a quarter of the world’s reported cases, according to Johns Hopkins University data. The death toll in the U.S. has reached more than 182,000.
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