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FDA updates COVID-19 testing guidelines to allow self-swab tests

By Darrell Etherington

The U.S. Food and Drug Administration (FDA) has updated its guidelines for COVID-19 testing procedures, in a bid to both make the process easier and less uncomfortable for patients, and to help limit the impact of testing on the supply of personal protective equipment (PPE) used by healthcare workers, including protective masks, face shields, gloves and gowns.

The change means that people undertaking a test will be able to conduct their own swab, which will involve swabbing shallowly in their nose. The existing process required a healthcare professional to take the swab, and to collect a sample from further up in the nasal cavity. This change does not mean there’s any difference in the FDA’s guidance regarding at-home sample collection – that is still specifically disallowed by the agency’s rules, something the FDA clarified over the weekend in order to put an end to at-home test collection kits being distributed by diagnostic startups.

Individuals will still have to go to authorized clinical or drive-through testing sites, and will still have to meet the Centers for Disease Control and Prevention (CDC)’s screening requirements in order to get tested in the first place. But Vice President Mike Pence said that this will mean that testing conditions are safer for frontline medical personnel, in addition to lowering the drain on PPE resources.

Pence also added that all state and private labs now required by law to report all of their results by law to the CDC, whereas previously, some states were reporting only positive results, which obviously skewered the data in terms of the number of people in the U.S. tested and the resulting positive diagnoses.

Fiat Chrysler to start producing 1 million face masks a month

By Kirsten Korosec

Fiat Chrysler Automobiles said Monday it will start manufacturing face masks in the coming weeks and donate the critical medical equipment to first responders and health care workers — the latest automaker to direct its manufacturing expertise towards the COVID-19 pandemic.

The automaker confirmed to TechCrunch that production capacity is being installed this week at one of its factories in China. Manufacturing will start in the coming weeks and distribution will be focused on the U.S., Canada and Mexico. FCA said it plans to produce 1 million face masks a month. All of masks will be donated to police, EMTs and firefighters and workers in hospitals and health care clinics.

“Protecting our first responders and health care workers has never been more important,” FCA CEO Mike Manley said in a statement. “In addition to the support we are giving to increase the production of ventilators, we canvassed our contacts across the healthcare industry and it was very clear that there is an urgent and critical need for face masks. We’ve marshalled the resources of the FCA Group to focus immediately on installing production capacity for making masks and supporting those most in need on the front line of this pandemic.”

The FCA announcement follows a plea last week from Vice President Mike Pence for construction companies to donate their stocks of N95 respirator masks to hospitals. Construction companies have responded, Pence said in a subsequent press conference. Other companies have started donating their caches of face masks as well, including Apple, Facebook, IBM and Tesla.

COVID-19, a disease caused by coronavirus, has led to a shortage of protective equipment such as N-95 respirator masks, gloves and gowns.

Vice President Pence asked construction companies to donate to their local hospitals their stocks of N95 respirator masks and stop ordering more for the time being. This call comes in the middle of a major shortage of these kinds of masks, which get their name from being able to block at least 95% of 0.3 micron particles.

Other manufacturers such as GM, Ford, VW and Tesla have started to work on the complex task of producing ventilators, another critical piece of medical equipment for patients who are hospitalized with COVID-19. The disease attacks the lungs and can cause acute respiratory distress syndrome and pneumonia. And since there is no clinically proven treatment yet, ventilators are relied upon to help people breathe and fight the disease. There are about 160,000 ventilators in the United States and another 12,700 in the National Strategic Supply, the NYT reported.

GM said Friday that it is working with Ventec Life Systems to help increase production of respiratory care products such as ventilators. Tesla CEO Elon Musk said last week that he had a discussion with Medtronic about ventilators. Medtronic later confirmed those talks in a tweet. Musk had previously tweeted that SpaceX and Tesla will work on ventilators, without providing specifics.

Vice President Mike Pence will lead the US response to the COVID-19 outbreak

By Jonathan Shieber

In an early-evening press conference, President Donald Trump tapped Vice President Mike Pence to lead the U.S. response to the COVID-19 outbreak that has spread through Europe, Asia and Latin America.

The new coronavirus strain, which has infected about 81,000 people around the world and killed 3,000, has already wrought havoc on the global economy. The Centers for Disease Control and Prevention warned yesterday that the U.S. will likely not be able to escape the spread of the virus.

“It’s not a question of if this will happen but when this will happen and how many people in this country will have severe illnesses,” said Dr. Nancy Messonier, director of the National Center for Immunization and Respiratory Diseases, in a press conference given by the Centers for Disease Control on Tuesday. “Disruption to everyday life might be severe.”

Earlier this evening, California reported its first case of community transmission, which was confirmed by the Centers for Disease Control, according to The New York Times. That’s a case where an infected person was not exposed to anyone known to be infected with the virus and had not traveled to countries where the virus had spread.

THREAD: On New #COVID19 Diagnosis in California Tonight: We will have community spread of #coronavirus in the U.S. It is likely that we have — right now — more cases that remain undiagnosed but will soon be revealed. We need to keep in mind several key points: 1/n

— Scott Gottlieb, MD (@ScottGottliebMD) February 27, 2020

Speaking alongside Pence; Health and Human Services Secretary Alex Azar; National Institute of Allergy and Infectious Diseases head Dr. Anthony Fauci; and principal deputy director of the Centers for Disease Control Dr. Anne Schuchat, the President stressed that the U.S. government was “very, very ready” to respond to the disease.

Vice President Pence said that the White House would continue to work closely with state and local officials, add additional personnel and work with Congress to ensure that the necessary resources are available. “The threat to the American public remains low,” Pence said.

The White House is asking Congress for $2.5 billion to support efforts to stop the spread of the virus in the U.S. while Senate Democrats led by Chuck Schumer have put an $8.5 billion price tag on the coronavirus fight.

Secretary Azar outlined five areas where the government would look to spend money including: monitor the spread of the virus, cooperate with local governments, develop therapeutics, develop vaccines, and manufacture and purchase personal protective equipment.

Diagnosing the illness has been a particular problem for the U.S. According to multiple reports, the CDC isn’t prepared to test for a potentially rapidly expanding number of cases in the U.S.

Only 12 of the 100 public health labs in the U.S. are able to diagnose the coronavirus because of problems with a test developed by the CDC, according to a Politico report.

Better diagnostics tools are going to be one of the critical areas where startups could play a role in combating the spread of the virus.

“Where startups are going to make contributions is in detection, monitoring, epidemiological predictions, sequencing, supply chain [and] distribution logistics,” wrote James Birch, an entrepreneur and former researcher with the American College of Surgeons.

Scott Gottlieb, the former Food and Drug Administration chief and an investor with New Enterprise Associates, has advocated for the expansion of Emergency Use Authorizations from the organization he used to lead as a way to respond to the need for more, better diagnostic tests.

THREAD ON DIAGNOSTICS: In recent public health emergencies there’s been a stepwise approach to ramp up U.S. testing capacity. CDC develops test early in outbreak, then pursuant to Emergency Use Authorization (EUA) from FDA CDC makes test available to network of public health labs

— Scott Gottlieb, MD (@ScottGottliebMD) February 24, 2020

The lack of effective tests available to public health facilities calls into question exactly how prepared the government is for the potential health crisis. In fact, the White House got rid of the pandemic response group in the Administration in a cost-cutting measure in 2018.

Also troubling to some healthcare observers is Pence’s own track record when it comes to healthcare crises.

As governor of Indiana, Pence’s inaction led to an outbreak of HIV in one of the state’s more rural counties, according to a report in HuffPost. As drug use soared in the state during the opioid crisis, addicts in the county were also becoming infected with the virus because they were sharing needles. Pence opposed a needle-sharing program, which could have limited the spread of the virus.

Fears about how the new coronavirus would impact the economy rattled stock markets earlier this week as news of the disease’s spread to Europe were confirmed. The market’s slide and the political response in Washington played a role in the president’s decision to hold a press conference today, judging by the president’s own Twitter account.

Low Ratings Fake News MSDNC (Comcast) & @CNN are doing everything possible to make the Caronavirus look as bad as possible, including panicking markets, if possible. Likewise their incompetent Do Nothing Democrat comrades are all talk, no action. USA in great shape! @CDCgov…..

— Donald J. Trump (@realDonaldTrump) February 26, 2020

Anomalous data can lead to growth opportunities

By Walter Thompson
Julian Shapiro Contributor
Julian Shapiro is the founder of BellCurve.com, a growth marketing team that trains startups in advanced growth, helps you hire senior growth marketers and finds you vetted growth agencies. He also writes at Julian.com.

We’ve aggregated many of the world’s best growth marketers into one community. Twice a month, we ask them to share their most effective growth tactics, and we compile them into this growth report.

This is how you stay up-to-date on growth marketing tactics — with advice that’s hard to find elsewhere.

Our community consists of 1,000 startup founders and VPs of growth from later-stage companies. We have 400 YC founders, plus senior marketers from companies including Medium, Docker, Invision, Intuit, Pinterest, Discord, Webflow, Lambda School, Perfect Keto, Typeform, Modern Fertility, Segment, Udemy, Puma, Cameo and Ritual .

You can participate in our community by joining Demand Curve’s marketing webinars, Slack group or marketing training program.

Without further ado, on to our community’s advice.

No one wants your $25 referral bonus

Insights from Julian Shapiro of Demand Curve.

Even people who earn minimum wage can’t be bothered to refer a friend for a $25 referral fee. The most successful referral programs typically focus on app features that naturally incentivize users to invite friends and colleagues.

Court rules Mike Rothenberg must fork over more than $31 million to settle SEC allegations

By Sarah Buhr

Mike Rothenberg, the once high-flying VC bent on bringing the party to Silicon Valley, must now pay a whopping $31.4 million to settle a California federal court ruling in favor of Security and Exchange Commission allegations.

TechCrunch deemed Rothenberg a “virtual Gatsby” back in 2016, when we first broke the news about the downfall of his venture capital firm, Rothenberg Ventures. It seemed he took it as a compliment, changing his Instagram handle to @virtualgatsby. Indeed, the name seemed appropriate for a man who seemingly lived a party-boy lifestyle and spent lavishly to woo startup founders — including going on Napa Valley wine tours, holding an annual “founder field day” where he rented the whole San Francisco Giants’ baseball stadium and spending unsparingly to executive produce a video for Coldplay.

But the party life came to a halt when top leadership jumped ship and the SEC started looking into the books. The SEC formally charged Rothenberg in August of 2018 for misappropriating millions of dollars of his investors’ capital and funneling that money into his own bank account. Rothenberg settled with the SEC at the time and, as part of the settlement, was barred from the brokerage and investment advisory business for five years.

Rothenberg was later caught up in several lawsuits, including one from Transcend VR for fraud and breach of contract, which ended in a settlement. Another suit between Rothenberg and his former CFO, David Haase, ended with Rothenberg being ordered to pay $166,000 in damages.

But there was more to come from the SEC, following a forensic audit in partnership with the firm Deloitte showing the misuse or misappropriation of $18.8 million in investor funding. Under that examination, Deloitte showed Rothenberg had used the money either personally, to float his flashy lifestyle, or for other extravagances, such as building a race car team and a virtual reality studio. Rothenberg has now been ordered to pay back the $18.8 million he took from investors, another $9 million in civil penalties, plus $3.7 million in interest.

Neither the SEC nor Rothenberg have responded for comment. It’s also important to note none of the charges so far have been criminal, but were handled in civil court, as the SEC does not handle criminal cases.

Through all of it, Rothenberg never admitted any guilt for his actions and it is important to note that, because of this he will be able to practice again after the bar is lifted in five years. He’s also made some decent early investments in startups like Robinhood, and many investor sources TechCrunch spoke to over the years seemed quite loyal to him as an investor, despite the charges, employee mass exodus and fund implosion that followed.

And it seems this saga is not over yet. Rothenberg told MarketWatch in a recent interview that he thought the ruling was, “historically excessive and vindictively punitive,” that he planned to appeal it and would be suing Silicon Valley Bank, which Rothenberg used to funnel several investments, over the matter.

Rothenberg Ventures already filed suit against Silicon Valley Bank in August of 2018, the same day the SEC filed formal charges against Rothenberg himself. In that suit, Rothenberg alleged negligence, fraud and deceit on the part of the bank and sought a trial before jury. Silicon Valley Bank said it would defend against the case at the time.

We’ve reached out to Silicon Valley Bank and are waiting to hear back. The real question is, if Rothenberg were to come back to investing in Silicon Valley, would anyone still trust him?

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