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White Home threatens to fireplace FDA chief until Covid vaccine OKed Friday: experiences

US President Donald Trump and Stephen Hahn, Director of the Food and Drug Administration, attend the daily meeting of the coronavirus task force at the White House in Washington, DC on April 24, 2020.

Drew Angerer | Getty Images

White House chief of staff, Mark Meadows, has urged the head of the Food and Drug Administration to resign if the agency does not clear Pfizer’s coronavirus vaccine for emergency use by the end of the day, the Washington Post reported on Friday.

The warning prompted FDA Commissioner Stephen Hahn and the agency to accelerate their schedule for the release of America’s first Covid-19 vaccine from Saturday morning to late Friday, according to the Post, citing anonymous sources.

The New York Times, Axios, and Reuters also reported that Meadows urged Hahn to resign if he wasn’t quick enough to remove the vaccine.

In a statement, Hahn called the Post’s report “an untrue account”.

“This is an untrue representation of the telephone conversation with the chief of staff,” Hahn told CNBC on Friday afternoon. “The FDA has been encouraged to continue working swiftly on Pfizer-BioNTech’s EEA request. The FDA is committed to swiftly granting this approval, as we noted in our statement this morning.”

The White House did not immediately respond to CNBC’s request for comment.

The reports come a day after a key FDA advisory body voted 17-4, with one abstention, to recommend the vaccine, which Pfizer partnered with BioNTech, for emergency approval. The FDA typically follows the recommendations of the Advisory Committee on Vaccines and Related Biological Products. After the overwhelming vote, the FDA should release the vaccine on Friday.

Hahn said earlier that day the agency was “working fast” to clear Pfizer’s emergency vaccine. “The agency has also notified the US Centers for Disease Control, Prevention and Operation Warp Speed ​​so they can implement their plans for timely vaccine distribution,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.

Shortly after Hahn ’s remarks, President Donald Trump, who has repeatedly urged the FDA to speed up the vaccine development process, tweeted the agency,” Get the dam vaccines out NOW. “

“Stop playing and save lives !!!”

FDA approval would mark a record-breaking timeframe for a process that typically takes about a decade. The fastest vaccine development to date against mumps took more than four years and was licensed in 1967. Pfizer and BioNTech announced plans to develop a coronavirus vaccine in March and filed an emergency clearance application with the FDA in November.

An emergency permit, or EEA, is not the same as a full permit, which can typically take months. Pfizer has only submitted safety data for two months, but it typically takes the agency six months for full approval.

– CNBC’s Amanda Macias contributed to this report.

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Business

Lululemon (LULU) stories Q3 2020 earnings, gross sales beat estimates

Lululemon Athletica store exterior, Ponce City Market.

John Greim | LightRocket | Getty Images

Lululemon reported sales of $ 1.1 billion on Thursday, up 22% year over year, beating analysts’ estimates as shoppers visited the retailer’s stores and website to purchase workout clothes during the reporting period.

In North America, net sales increased 19% driven by the e-commerce business. Overall, direct sales to consumers increased 94%, representing 42.8% of total sales, compared to 26.9% a year ago. This represents the sales that Lululemon makes directly to consumers through its stores and website with no intermediaries.

Due to the uncertainty surrounding the Covid-19 pandemic, which has forced it to temporarily close a handful of its stores again, Lululemon doesn’t offer a full outlook for 2020. Like others in retail, Lululemon faces the risk of additional store closings Coronavirus- Cases are still increasing in the US and other parts of the world.

However, CFO Meghan Frank noted that the company planned the holiday quarter “based on multiple performance scenarios” and believes it is “well positioned” for the holiday season. During the week of Thanksgiving and Black Friday, the company announced that its online business was generating record sales, offsetting the decline in store traffic.

Lululemon shares started to make gains, falling around 1% in after-hours trading shortly after 5pm. As of Thursday’s close of trading, Lululemon shares were up more than 59% year-to-date, bringing the company’s market cap to $ 48.1 billion.

Here’s how the retailer performed in the third quarter of fiscal year compared to analyst expectations based on refinitive data:

  • Earnings per share: $ 1.16, adjusted versus 88 cents expected
  • Revenue: $ 1.12 billion versus $ 1.02 billion expected

For the quarter ended November 1, Lululemon made $ 143.6 million, or $ 1.10 per share, compared to $ 126 million, or 96 cents per share, a year ago. Without a one-time charge, the company made $ 1.16 per share, better than what analysts had expected to be 88 cents.

Net sales rose 22% to $ 1.12 billion, beating analysts’ estimates of $ 1.02 billion.

In-store sales, tracking sales online and in stores that have been open for at least 12 months, increased 19%.

The company said sales for women were up 22% year over year, while those of men were up 14%.

While the entire apparel category has struggled this year, Lululemon is a retailer that has taken advantage of more consumers focusing on exercising at home during the pandemic and opting for comfortable sportswear over dresses and suits.

“While a V-shaped rebound may not happen for most of the apparel retail sector, Lululemon has recovered from a poor start to the year with impressive third quarter numbers,” said Neil Saunders, managing director of GlobalData Retail.

“Our data also shows that Lululemon has attracted a lot of new buyers, especially in women’s fashion,” he added.

Earlier this year, Lululemon also acquired home exercise equipment maker Mirror for $ 500 million to compete with the likes of bike maker Peloton. During the quarter, Lululemon announced it had started selling the startups’ $ 1,500 mirror-like devices in 18 stores and on its website.

The full press release on the result can be found here.