Raphael Stevens

Merck said it asked the FDA to authorize emergency use of its experimental antiviral pill to treat mild to moderate Covid-19 in adults.
“The topline data from this Merck study was probably the best treatment effect we’ve seen from orally available antiviral drug in the treatment of any respiratory pathogen, so this can make a real difference,” said Dr. Scott Gottlieb.

Dr. Scott Gottlieb explained why he’s optimistic about Merck’s Covid antiviral pill after the drugmaker asked the Food and Drug Administration Monday to authorize its pill to treat people with mild to moderate Covid symptoms. 
“The topline data from this Merck study was probably the best treatment effect we’ve seen from orally available antiviral drug in the treatment of any respiratory pathogen, so this can make a real difference,” said the former FDA chief in the Trump administration. 

If the agency signs off on the drug, it will be the first pill shown to work against Covid-19 and Americans could get it by the end of the year. 
Gottlieb told CNBC’s “The News with Shepard Smith” Merck’s pill is part of an “overall, significant improvement in our therapeutic toolbox against this virus, not just with vaccines and therapeutics, but also with more accessible diagnostic tests.”
Host Shepard Smith also asked Gottlieb about masking rules across the country. Gottlieb told Smith that he thinks decisions will be made at a local level and noted the varying prevalence of the delta variant across the U.S. 
“We’ve seen sharp declines in the south, where delta’s largely run its course, so cases are coming down very sharply in populous states like Texas and Florida, but you’re seeing pretty dense epidemics in the midwest and plain states, and we still don’t know how the northeast and the northern states are going to fare,” Gottlieb said. 
He predicted that a Covid-19 delta wave could hit northern U.S. states, despite higher vaccination rates and higher prior infection rates. 

“I still think that there’s a delta wave that’s going to sweep across the northern states, as well in the northeast, it’s not going to be nearly as dense as what you saw in the south, but we still are probably in store for more spread,” Gottlieb said.
Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the boards of Pfizer, genetic testing start-up Tempus, health-care tech company Aetion Inc. and biotech company Illumina. He also serves as co-chair of Norwegian Cruise Line Holdings’ and Royal Caribbean’s “Healthy Sail Panel.”

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Southwest has canceled more than 2,000 flights since Saturday.
The airline blamed air traffic control issues, bad weather and its own staffing shortage.
Outraged customers complained about long hold times to change flights.

Southwest Airlines shares slipped Monday after it canceled more than 2,000 flights since Saturday, disrupting the travel plans of thousands of people.
Southwest’s operation improved since the weekend meltdown but cancellations continued. It scrapped 363 flights on Monday, down from 1,124 on Sunday, which was 30% of its schedule, according to flight-tracking site FlightAware. 

The airline has already said it would trim its fall schedules to avoid cancellations and delays that plagued its operation during the summer. Now the carrier is weighing whether it needs to cut more.
Mike Van de Ven the Dallas-based airline’s COO who was also promoted to president last month, told staff late Sunday that Southwest is still short-staffed and “we’ll need to continue to adjust our schedules as this environment evolves.”

Travelers wait to check in at the Southwest Airlines ticketing counter at Baltimore Washington International Thurgood Marshall Airport on October 11, 2021 in Baltimore, Maryland.
Kevin Dietsch | Getty Images

“We’ve already made significant reductions from our previously published November and December schedules, and if we think we need to do more, we will,” Van de Ven said in a recorded message to employees, which was reviewed by CNBC.
Southwest shares lost 4.2% on Monday to close at $51.67. American added 0.3% to end at $20.13, United was nearly unchanged at $49.18, and Delta fell 0.4% to $43.19.
In August, Southwest reduced its schedule in hopes of fixing its operational struggles over the summer that regularly led to dozens of flight cancellations. Pilots, flight attendants and other staff complained about exhaustion from their grueling schedules.

The weekend’s issues came amid speculation that they were driven by staff’s excessive sick calls tied to a federal vaccine mandate for government contractors that Southwest told employees this month it would enforce this fall.
Southwest said that was “inaccurate” and “unfounded.” Casey Murray, president of the Southwest Airlines Pilots Association said pilot sick calls were in line with averages seen over the last few months as were the numbers of crews picking up open shifts, but declined to provide specifics.
The airline, like some of its rivals, has been struggling with staffing shortfalls for months. Southwest and other carriers urged staff to take buyouts or leave during the peak of the coronavirus pandemic, only to have demand bounce back faster than expected.
Van de Ven, Southwest’s president, acknowledged the airline “is still not were we need to be on staffing, and in particular with Flight Crews.”
“Our models use various assumptions” for the use of backup staff, known as reserve, open trips, weather, as well as sick time and overtime and “we seem to be closer to those levels during the week and then the staffing is tight during the weekends.”

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Millions of Americans will be one step closer to receiving a Covid booster shot when a key FDA panel meets this week to debate extra doses of the Moderna and J&J vaccines.
The Biden administration hopes boosting the U.S. population will ensure long-term and durable protection against severe disease.
“Even with delta, the current vaccines are holding up quite well as far as hospitalization and severe disease,” said Norman Baylor, former director of the FDA’s vaccines office.

Millions of Americans will be one step closer to receiving a Covid-19 booster shot this week when a key Food and Drug Administration advisory panel meets Thursday and Friday to debate extra doses of the Moderna and Johnson & Johnson vaccines.
The FDA’s Vaccines and Related Biological Products Advisory Committee meetings come less than a month after U.S. regulators authorized Covid booster shots of Pfizer and BioNTech’s vaccine to a wide array of Americans, including the elderly, adults with underlying medical conditions and those who work or live in high-risk settings like health and grocery workers.

Anjali Sundararaman, a student nurse at San Francisco State University, administers a dose of Moderna COVID-19 vaccine to Cuixia Xu during a vaccination clinic at the Southeast Health Center in the Bayview-Hunters Point neighborhood in San Francisco, California on Monday, Feb. 8, 2021.
Stephen Lam | San Francisco Chronicle | Hearst Newspapers via Getty Images

More than 7 million Americans have received a booster dose in the U.S. as of Saturday – according to the latest data available from the CDC.
Members on independent committees of the FDA and Centers for Disease Control and Prevention said at the time they were frustrated that only Pfizer recipients would be eligible to get the extra shots, leaving out millions of Americans who got Moderna’s or J&J’s shots.

CNBC Health & Science

The FDA advisory group is scheduled Thursday to discuss data on the safety and effectiveness of a Moderna booster shot in adults. On Friday, the committee is expected to debate J&J booster shots for adults. The FDA could make a final decision within days of the meetings, handing it off to the CDC and its vaccine advisory committee to make their own decision.
The CDC’s next vaccine advisory meeting is scheduled for Oct. 20 to Oct. 21 where it’s expected to discuss the boosters.
The FDA meeting comes after average daily Covid cases in the U.S. fell below 100,000 last week with more than 56% of the population fully immunized against the virus and the pandemic showing signs of easing. Getting vaccinated, receiving booster shots and avoiding large gatherings are crucial ways to mitigate a possible surge in cases over the holidays, health experts say.

The Biden administration hopes boosting the U.S. population will also continue to ensure long-term and durable protection against severe disease, hospitalization and death as the fast-moving delta variant spreads.
The strain led to a surge in hospitalizations in the U.S., mainly among the unvaccinated. Still, some vaccinated Americans have suffered so-called breakthrough infections and just over 19,000 of them – less than 1% – have been hospitalized or died with Covid as of Sept. 20, according to data compiled by the CDC.
“Even with delta, the current vaccines are holding up quite well as far as hospitalization and severe disease,” said Norman Baylor, former director of the FDA’s vaccines office. “It’s the infections that seem to be a concern.”
Last month, Moderna said a third shot at half the dosage used for the first two jabs was safe and produced a stronger immune response than what was seen after the second dose in its phase three clinical trial.
J&J said last month a second dose of its single-shot vaccine was safe and boosted protection against symptomatic infection from around 70% to 94% when administered two months after the first dose in the United States.
The FDA could authorize Moderna and J&J booster shots under the same criteria as Pfizer or perhaps change course and broaden the number of Americans eligible to receive extra shots, Baylor said in a phone interview.
“The question is: does everybody need a booster right now?” said Baylor, now president of Biologics Consulting Group.
Committee members will have to debate whether its safe and effective for J&J recipients to get a second dose, Baylor said. He added he doesn’t expect any trouble authorizing third doses of Moderna’s vaccine as it uses mRNA technology, which was also used to develop Pfizer’s vaccines.
“If I were at the FDA in my old position, I probably would not have taken the Moderna to the advisory committee because it’s in the same class as Pfizer,” he said.
The administration’s communication on Pfizer booster shots was already confusing and “very damaging” in terms of public perception, said Dr. Isaac Bogoch, an infectious disease specialist at the University of Toronto.
“From the outside looking in, it looks like a bit of a free-for-all,” Bogoch said. “Like, yeah there’s some loose guidance in the United States. But it basically looks like anyone can go into any pharmacy and get a booster shot and say you know what I smoke or I’m obese or I’m a health-care worker.”

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Amid market and political uncertainty, there are steps you can take to protect your portfolio.
If you confirm your investments’ resilience, understand their financial health and determine if selling is warranted, you will have a higher likelihood of keeping the money you’ve made and long-term investment goals.
While investment managers are more rigorous, they basically go through the same steps. Now you have a strategy to hang onto hard-earned profits.

LeoPatrizi | E+ | Getty Images

More than a year and a half of concerns about inflation, rising interest rates and extreme government spending have increased the uncertainty of the investment markets. For this reason, it is imperative for seasoned and novice investors alike to protect their portfolios.
I like to call this “bullet-proofing” your portfolio. There are some steps to take that will assist in this process.

The first is to review your stock’s resilience.
During the pandemic, the traditional rules of investing in established companies with strong revenue and profits seemed to have been tossed aside. According to Credit Suisse, one of the best performing styles in 2021 has been the basket of stocks with a high probability of defaulting on the firm’s debt.
Through Aug. 31, the stocks of these potentially defaulting companies were up more than 28% for the year, while the S&P 500 came in around 20%.
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However, in September, the markets provided investors with a reality check. The S&P 500 was down 4.8% for the worst month since March 2020.

What was the issue? Perhaps it was stubborn inflation, the possibility of rising interest rates or even continued supply chain problems, resulting in companies being unable to meet their earnings expectations for the remainder of 2021 and beyond?
As companies begin to report their third-quarter earnings, investors will find out exactly what happened.
If expectations for companies’ future earnings get cut, the market will not be kind, and these companies’ stock prices will tumble. Stocks with the loftiest valuations are the most venerable. It’s time to test your investments’ ability to withstand current headwinds and determine if they are indeed resilient.
A resilient company is one that can weather the volatility that comes with operating during a full economic cycle, including a recession. Will the company survive if its sales or profit margins decrease? Over the long-term, companies, just like your household, need consistent and positive cash flow.

Access to cash typically comes from two places. One source is sales of a company’s product (the company’s operations.) The second is financing through either loans (debt) or issuing new stock in the company.
Companies that have been established for a long period of time should have strong enough sales and profits so that rounds of new debt or stock issuance are not necessary. On the other hand, a company that has a new technology or a non-conventional product may need new financing for several years until its sales and profits become strong.
Both types of companies can be deemed resilient and therefore, less likely to suffer a major pullback in their stock prices.

Taking a deep dive

Now, take a deep dive into the financial health of your investments.
While confirming your investment’s cash flow resilience is a good start, there are a few additional numbers and statistics that can be indicators of potential problems. The following data will further test financial health:
Earnings and revenue growth: Review whether the company’s earnings and revenue in the most recent years are higher than earnings and revenue in previous years. At the minimum, one would want to see that earnings and revenue growth is on a positive trend. Of course, companies that are considered innovators in technology or medicine may need to be given some leeway.

Levels of debt and stock on the balance sheet: Compare the current dollar amounts of both debt and stock on the company’s balance sheet to the past two to three years. Are either of these increasing significantly from one year to the next?
Next, review the company’s revenues and net income, both of which can be found on the company’s earnings statements. Are these decreasing?
If the answer is yes to both of these questions, the company’s cash flow from its operations is declining and they are making up the difference by going to the bank — and/or shareholders.
The good news is that you don’t need to be a financial analyst to find the answers to the above questions. The information is readily available through quarterly earnings announcements. Search the company’s website or review past financial press releases.
Now that you understand the numbers, you need to know how and when to play it safe and when to take risks.
Companies are starting to warn that the consequences of inflation and supply-chain bottlenecks will create an inability to meet expectations from Wall Street. Over the past three months, profit margin estimates have been decreased for 140 companies in the S&P 500. When sales or profit estimates are cut for a company, so is its stock price.

We are entering a period where companies that disappoint will be punished more severely than in the past. The reason for this is extreme valuations and stocks that are priced for perfection. In preparation, understand your company’s degree of financial strength during a complete economic cycle.
Evaluate your company’s pricing power, its inelasticity of demand for its goods and services, as well as its ability to meet current demand. Also, estimate how the metrics that were highlighted above will be impacted during a longer period of inflation and lower growth.
With your new understanding of your investment’s cash flow resilience and financial metrics, you are ready to determine how much you can potentially make or potentially lose when it reports its earnings in just a few weeks. Failure to do so may result in harsh penalties.
There are also steps you can take to preserve those gains.

How to hold onto gains

Monty Rakusen | Image Source | Getty Images

Approach your portfolio of companies in the same manner as an institutional manager by estimating how much upside and downside that the stock may have over the next 12 months.
Evaluate how lower sales and/or decreasing profit margins may affect the share price. Go back and look at how the company has fared during past recessions or lower profitability.
It’s not a complicated calculation. Spreadsheets are not required.
If your estimated upside percentage is the same or lower than the estimated downside percentage, take profits and or sell the position. For example, if you think that there is only a 10% upside for the stock over the next 12 months, but your potential downside is 15%, then by all means, sell some.
If you are uncomfortable with percentage calculations, review your company’s estimates for its earnings and watch how your stock’s price is acting in the market. If the markets are pulling back and if your position is falling, set a point where you sell all or part of it. If markets keep moving upward, review the stock’s price estimates. As the price gets closer to the consensus target and if you agree with the analysis, take some profits.
The past 18 months have been profitable and relatively easy for investors. However, economic and political uncertainty is increasing the chances for a market correction — and watching your gains disappear.
Now is the time for investment discipline. The strategy outlined above will provide this discipline.
If you confirm your investment’s resilience, understand its financial health and determine if selling is warranted, you will have a higher probability of retaining the money that you have made and reaching your long-term investment goals.
While investment managers are more rigorous, they basically go through the same steps. Now you have a strategy to hang onto your hard-earned profits.

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Merck said it asked the FDA to authorize emergency use of its experimental antiviral pill to treat mild to moderate Covid-19 in adults.
Phase three clinical trial data showed that the drug – known as molnupiravir – reduced the chances that patients newly diagnosed with Covid would be hospitalized by about 50%.
The experimental drug could be available to Americans by late this year.

Merck said Monday it has asked the Food and Drug Administration to authorize emergency use of its experimental antiviral pill to treat mild to moderate Covid-19 in adults.
The U.S. drugmaker’s request came after phase three clinical trial data released Oct. 1 showed that the medication – known as molnupiravir – reduced the chances that patients newly diagnosed with Covid would be hospitalized by about 50%.

The drug works by inhibiting the replication of the virus inside the body. Unlike Gilead Sciences’ intravenous drug remdesivir, Merck’s molnupiravir can be taken by mouth. If approved by U.S. regulators, it would be the first pill to treat Covid, a potentially game-changing advancement in the fight against the virus, which is killing an average of more than 1,600 Americans per day.
“The extraordinary impact of this pandemic demands that we move with unprecedentedurgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Merck CEO Robert Davis said in a press release.
The pill could be available to Americans by late this year. Merck, which developed the drug with Ridgeback Biotherapeutics, said it is actively working with regulatory agencies worldwide to submit applications for emergency use or authorization “in the coming months.”
The company agreed earlier this year to supply the U.S. with around 1.7 million courses of molnupiravir if it receives emergency use authorization or full approval from the FDA. According to The New York Times, a five-day course of the medication will cost the federal government about $700 per patient, a third of the current cost of monoclonal antibodies.
While vaccinations remain the best form of protection against the virus, U.S. officials and health experts hope a pill like Merck’s will keep the disease from progressing in those who do get infected and prevent trips to the hospital.

Pills like Merck’s are considered a sort of “holy grail” for treatments, Dr. Mike Ryan, executive director of the World Health Organization’s Health Emergencies Program, said at a news conference last week.
Other drugmakers are also working on antiviral pills. One created by Pfizer, which developed the first authorized Covid vaccine in the U.S. with BioNTech, could be available by the end of this year, Pfizer CEO Albert Bourla told CNBC in April.

CNBC Health & Science

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