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Saturday, October 12, 2019

SmileDirectClub Has Given Back Most Its IPO-Driven Valuation Gain

Morning Markets: Today in “oh crud, that’s not recurring revenue!”
When SmileDirectClub was going public, things looked great for the at-home, teeth-straightening company. After raising over $400 million while private, SmileDirect’s IPO pricing cycle went terrifically. The company initially set a $19 to $22 per-share IPO price range before selling nearly 60 million shares at $23 apiece.

The new per-share price valued SmileDirectClub at around $8.9 billion. For the Nashville-based company, that new valuation was rich and welcome. By pricing where it did, SmileDirect raised over $1 billion with minimal dilution, at least compared to what it would have cost the firm to raise the same sum at its old valuation.
That prior valuation was a fraction of the firm’s IPO worth. Indeed, when SmileDirectClub last raised known private capital, back in October of 2018 (just one year ago), investors valued it at a smidge under $3.2 billion after counting the value of the $380 million infusion.
Given that the company managed to squeeze a 178 percent gain in value in under a year when it went public, perhaps we should have better forecasted what came next.
Namely this:
SDC Chart
As we reported at the time, SmileDirectClub’s shares were instantly spat out by the public markets, closing at $16.67 on their first day of trading, a 28 percent decline.
Today the company is worth just over $10 per share, off 55.5 percent from their IPO price ahead of trading today. That’s a stunning repudiation, bringing the company to a somewhat embarrassing private-public value inversion. SmileDirect is in danger of seeing its public valuation fall under its final private valuation:
  • Final SmileDirectClub private valuation: $3.18 billion.
  • Current SmileDirectClub public valuation: $3.94 billion.
It’s not there yet, but the value of SmileDirectClub today is a shadow of what it was when its bankers got its IPO put together. (Oddly, this result is an endorsement of sorts for the traditional method of determining the value of a company. If SmileDirect had been valued fairly, it would have raised far less capital in its debut.)
One last thing before we go. If you observe the above chart, there are two lines. The orange line corresponds to the far-right axis. It’s SmileDirect’s trailing price/sales ratio. More simply it gives us a good idea of how investors are valuing the company’s top line.
As you can see, early in its life as a public company, even down from its IPO price, SmileDirectClub was able to garner a double-digit revenue multiple. Calculated on a forward basis that metric would shrink some, but a better question is why the firm was valued at over 10x revenue to begin with?
In retrospect, SmileDirect has all the things that public-market investors seem tired of:
  • Dual-class share structure.
  • Scaling losses as the firm grew.
  • A recent sales and marketing expense boom.
  • Majority non-recurring revenue.
To its credit, SmileDirectClub had rapidly scaling revenue (from $175.1 million in H1 2018 to $373.5 million in H1 2019), and strong gross margins (around 78 percent in H1 2019). Those two highlights weren’t enough to sustain a nearly $9 billion valuation.
We’re keeping an eye on SmileDirect, and will report if it does dip below its final private price. Sadly the company doesn’t report earnings until November 12th, so we still have a while to wait for new numbers.
SmileDirectClub Has Given Back Most Its IPO-Driven Valuation Gain

Seniors’ Antidepressant Use Soars, Depression Rates Unchanged

The number of adults aged 65 years or older who take antidepressants more than doubled during the past 2 decades, despite little change in the number of seniors diagnosed with depression, new research shows.
With an increase in the use of antidepressants, it was hoped that the prevalence of depression would decline significantly, “but we haven’t observed that in our study,” lead author Antony Arthur, PhD, University of East Anglia, Norwich, United Kingdom, told Medscape Medical News.
The study was published online October 7 in the British Journal of Psychiatry.

Appropriate Prescribing?

Data for the analysis came from the Cognitive Function and Ageing Studies, conducted between 1991 and 1993 and between 2008 and 2011.
Researchers interviewed more than 15,000 adults aged 65 years or older in England and Wales to see whether the prevalence of depression and antidepressant use had changed.
They used a standardized interview process to determine the presence or absence of symptoms of depression and then applied diagnostic criteria to determine whether the participant had “case level” depression ― a level of depression more severe than that characterized by minor mood symptoms, such as loss of energy, interest, or enjoyment.
Between the two comparable groups of persons interviewed 20 years apart, the prevalence of depression fell only slightly ― from 7.9% in the earlier period to 6.8% in the later period. However, the proportion of adults taking antidepressants jumped from 4.2% in the early period to 10.7% 2 decades later.
The researchers say it is unclear whether the observed increases in treatment reflect overdiagnosis, better recognition and prescribing, or the prescribing of antidepressant medication for conditions other than depression.
Most of those who took antidepressants did not have a diagnosis of depression, and there are several possible explanations for this, Arthur said.
“Sometimes treatment is given for mild depression which falls outside of our definition of depression ― much of the evidence for the effectiveness of antidepressants is for people with moderate or severe depression. Antidepressants are also used to treat other conditions, for example, neuropathic pain and sleep disorders,” he said.
Owing to the nature of the study design ― cross-sectional analysis of two cohorts aged 65+ 20 years apart ― “we can’t infer that older patients are prescribed antidepressants unnecessarily,” Arthur said.
“But we shouldn’t be complacent,” he added. “Regular review is key to ensure that opportunities to deprescribe where it is safe and sensible to do so are not overlooked.”
On the other hand, some patients have depression but are not taking antidepressants.
“Health providers need to be vigilant with this group to discern whether it’s unrecognized depression that would be responsive to treatment,” said Arthur.

Questions Raised

“This study raises a number of questions that are not easy to answer due to the study design and lack of information about the past history of clinical depression,” Ramin Mojtabai, MD, PhD, MPH, professor in the Department of Mental Health at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, told Medscape Medical News.
His own research suggests that the prevalence of mood and anxiety disorders and symptoms has not decreased, despite substantial increases in the provision of treatment, particularly antidepressants.
That study, published in World Psychiatry in 2017, was based on depression prevalence and antidepressant use data from 1990 to 2015 in Australia, Canada, England, and the United States.
“The quality of antidepressant treatment in community settings remains problematic,” said Mojtabai. “Many patients continue on the same medication regimen, although they could benefit from medication adjustment (eg, dose increase, augmentation, switching to other mediations),” he commented.
The study was funded by grants from the Medical Research Council, the UK Department of Health, the Alzheimer’s Society, the National Institute for Health Research Clinical Research Network in West Anglia and Trent, and the Dementias and Neurodegenerative Disease Research Network in Newcastle. Arthur and Mojtabai have disclosed no relevant financial relationships.
Br J Psychiatry. Published online October 7, 2019. Abstract
https://www.medscape.com/viewarticle/919774

Can Anticoagulants Prevent Alzheimer’s?

Treatment with an oral anticoagulant delays memory decline and the conversion to Alzheimer disease (AD) in mice. The finding should spark future studies to see whether use of direct oral anticoagulants has therapeutic value in AD, investigators say.
Prior studies have shown that patients with AD tend to have poor cerebral circulation, and there is increasing evidence that AD is associated with a chronic procoagulant state.
In the new study, long-term anticoagulation therapy with dabigatran (Pradaxa, Boehringer Ingelheim) inhibited thrombin and abnormal deposition of fibrin in a mouse model of AD.
After receiving dabigatran for 1 year, the mice had no memory loss, and there was no reduction in cerebral circulation. Dabigatran also reduced typical AD symptoms, including cerebral inflammation, blood vessel injury, and amyloid protein plaques.
“Dr Alois Alzheimer already more than a century ago said that this disease was a disease of the blood vessels of the brain, and this was forgotten over many years,” co–senior investigator Valentin Fuster, MD, PhD, director of Mount Sinai Heart in New York City, told Medscape Medical News. “We began to study this with the most modern technology in a mouse model of Alzheimer’s that is very similar to humans.”
The study was published online October 7 in the Journal of the American College of Cardiology.

“Fascinating Finding”

Fuster’s co–senior investigator is Marta Cortes-Canteli, PhD, Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain. Together with colleagues at the Rockefeller University in New York City and other centers, they tested the effects of dabigatran (60 mg/kg body weight over 24 hours on average) vs placebo on AD pathogenesis in a transgenic mouse model of AD (TgCRND8 AD mice) and their wild-type litter mates. The mice received dabigatran in their chow.
Treatment with dabigatran for 12 months prevented memory decline, cerebral hypoperfusion, and toxic fibrin deposition in the mice.
Dabigatran treatment also significantly reduced the extent of amyloid plaques, oligomers, phagocytic microglia, and the infiltration of T cells by 24%, 52%, 31%, and 32%, respectively. The drug also had beneficial effects on blood-brain barrier integrity.
“Frankly, it’s a very fascinating finding” and may help “redirect” research into the vascular aspect of AD, said Fuster.
“Therapeutics aimed at normalizing the prothrombotic environment present in AD, in combination with other disease-modifying compounds, might be instrumental in improving AD pathogenesis,” the researchers write.
“Of course, there is a significant distance between an animal model and a human, but the disease appears to be the same,” Fuster said. “The next step is to begin to understand this in humans through all the new technology that we have to assess the vessels of the brain and maybe to begin already to do some studies with anticoagulation in humans. We are meeting already to discuss it,” he added.

Many Unanswered Questions

Commenting on the findings for Medscape Medical News, Maria Carrillo, PhD, chief science officer for the Alzheimer’s Association, said there are many unanswered questions about the use of anticoagulants as a treatment for AD and that “it has possibilities and should be explored further.
“In the bigger picture, it is exciting to see a wide variety of new avenues for Alzheimer’s treatment being investigated more thoroughly,” Carrillo said.
One of the limitations of the use of anticoagulation for treating AD is the increased incidence of intracranial bleeding, which the authors acknowledge, Carrillo said. “While not evident in this study, not all anticoagulant drugs are the same. Plus, we know very little about the effect of long-term anticoagulation in a frail, aging, Alzheimer’s population,” she noted.
“At the same time, repurposing an already-approved drug like the one tested in this study ― where we already know something about safe doses and side effects ― can mean that it moves more quickly through the testing and approval process,” said Carrillo.
The study was funded in part by a proof-of-concept award from the Robertson Therapeutic Development Fund of the Rockefeller University and through grants from the National Institutes of Health. The authors and Carillo have disclosed no relevant financial relationships.
J Am Coll Cardiol. Published online October 7, 2019. Full text
https://www.medscape.com/viewarticle/919772

Being Overweight Wipes 4 Years From Life: New Report

A new report on obesity from the Organisation for Economic Co-operation and Development (OECD) makes for grim reading; it details that even just being overweight will slash almost 3 years from life expectancy, on average, with this figure rising to 4 years in the United States.
A decade ago, across the 36 nations in the OECD, on average one in five individuals was obese. That figure now stands at one in four, meaning an additional 50 million people live with obesity. And three of five people living in wealthy nations are considered overweight.
In some countries the statistics are even worse. In the UK, for example, two in three people are overweight and one in three is obese. And in the United States, as figures revealed last month, almost 40% of adults and nearly 20% of kids are obese.
In this, its first report on obesity for 10 years, the OECD stresses how nations can reap economic benefits, as well as public health gains, from investing in effective strategies to combat rising obesity rates.
"Policies aimed at reforming the obesogenic environment are the most important, and they are an excellent investment," Michele Cecchini, lead economist for public health at OECD, told a London press briefing held yesterday to launch the report and to coincide with World Obesity Day on October 11.
"Since our initial report a decade ago, we have made quite a lot of progress — certainly in terms of awareness [about obesity], and certainly in terms of government policies and awareness of industry," added Francesca Colombo, head of the Health Division at the OECD.
"But what we have done is not enough. Overweight and obesity take a heavy toll on the economy. It's really quite a striking picture," she emphasized.
"And childhood and morbid obesity have gone from a rare event to a common occurrence. Obesity now poses an alarming burden on individuals, societies, and economies in OECD countries and beyond," the report concludes.
 
 

Obesity Will Reduce Economic Growth; Can Physicians Help?

In the 250-page document entitled, "The Heavy Burden of Obesity: The Economics of Prevention," the OECD predicts how obesity and its related health complications will reduce annual economic growth in its member nations, which include the United States, UK, Belgium, France, Germany, Italy, Portugal, Spain, Chile, and Mexico.
On average, 50% of people have an unhealthy diet, 40% of waking time is spent in sedentary activities, one in three people don't do enough physical activity, and two in five don't eat enough fruit and vegetables.
As a result, unless the tide is turned, over the next 30 years nearly 60% of all new diabetes cases will be caused by overweight, as well as 18%, 11%, and 8% of all cases of cardiovascular disease, dementia, and cancer, respectively.
This will result in 462 million new cases of cardiovascular disease and 212 million cases of diabetes.
OECD countries will therefore spend, on average, $209 per person annually on treating high body mass index and its related conditions.
 
The United States, Germany, and the Netherlands will spend the most on obesity, at $645, $411, and $352 per head respectively.
For OECD countries on average, this equates to 8.4% of total health spending, although this is highly variable across nations.
 
The United States alone will spend nearly 14% of its health budget on obesity and overweight, for example.
 
Asked by Medscape Medical News at the press briefing what role physicians and other healthcare workers can play, Jason Halford, PhD, of the University of Liverpool, UK, and chair of the European Association for the Study of Obesity, said: "By and large, physicians believe their patients are not motivated or interested [in losing weight]. The doctors think nothing seems to work, and the patient takes the blame."
And Cecchini said healthcare professionals need more man hours and motivation to start to enact change.
 
"Doctors, especially general practitioners, don't have time to spend on counseling [for weight reduction] and we don't give them the right incentives," he said.
 
There was overall agreement that labeling obesity as a disease can only help in this regard, although Halford noted that "it hasn't necessarily driven policy change yet."
"There is bias in the health system and huge provider bias against obesity," he asserted.
 

Societal Costs: Every $1 Spent Tackling Obesity Will Save $6

The spiraling rate of obesity around the world is primarily "a response to obesogenic environments," Johanna Ralston, chief executive of the World Obesity Federation, told the assembled press in London.
 
Cecchini stressed that it is only with a range of policies — such as regulation of advertising, food and menu labeling, mass media campaigns, prescription of physical activity, mobile apps, school-based programs and workplace wellness schemes — enacted together that the needle will really start to move.
 
"Every dollar spent on preventing obesity generates an economic return of up to six dollars, making prevention interventions an excellent investment," said Cecchini.
 
"All of these interventions could pay for themselves," he stressed
 
"Properly implemented policies do make a difference. We know what works but we are not implementing it to the extent that it makes a difference," said Colombo.
 
For example, cutting the calorie content in fattening foods such as potato chips (crisps) and candy by 20% would avoid more than 1 million cases of chronic disease per year.
 
However, "Any one thing is not the answer. You've got to do a lot. But if you start doing it, you will see changes," Halford emphasized.
 
"But the good news is that there is momentum, and growing awareness," said Columbo.
 

"We Know What Works...The Devil Is in the Detail"

To show that there is hope if governments and other stakeholders take action, the experts gave examples of policies that are working well, while nevertheless stressing the tremendous amount of work that still remains to be done.
 
Among the most effective initiatives for fighting obesity is regulation of advertising of unhealthy food, with more than $5 in return investment for each $1 spent, the OECD said.
 
Almost as effective are food labeling initiatives and efforts to make workers less sedentary.
 
"When it comes to ticking boxes" enacting policies, "the devil is in the detail," Cecchini emphasized.
"How is the policy designed and implemented? There are large gaps. For example, only a tiny minority of countries makes front-of-label packaging regarding nutrients compulsory," he noted.
 
Making such policies compulsory is deemed essential for effecting real change, said Corrina Hawkes, direct of the Centre for Food Policy, City, University of London, UK.
 
Also essential, she added, is action "in all countries," otherwise the five to six major multinational companies that produce most processed food worldwide will just seek other markets, as they did with tobacco products, she noted.
 
She believes "regional collaboration" is best; for example, the whole of Latin America working together, or Europe, or Asia. "Global is too big," she said.
 
The experts also emphasized how important the targeting of childhood overweight and obesity will be for the bigger picture, and for the future.
 
Children with obesity are over five times more likely to have obesity as adults, with all the attendant problems.
 
Conversely, healthy weight children are 13% more likely to report good school performance.
 
And even though the outgoing chief medical officer in the UK has just this week called for more concerted action on childhood obesity, Ralston said yesterday that the strategy in the UK, including its "Atlas of Childhood Obesity," is one of the best so far in the world and "is to be emulated."
 

A Long Way to Go but Is There Is Light at the End of the Tunnel?

Over 46 countries in the world now regulate the marketing of unhealthy foods to children and 59 countries have implemented taxes on sugar-sweetened beverages.
 
But the majority of that regulation of advertising to children "is still focused on traditional old media," said Cecchini, and "new media" — which is increasingly what children consume — is not being regulated for the most part, although he singled out South Korea and the Canadian province of Quebec for their efforts in this area.
 
Meanwhile, Columbo singled out Chile, Mexico, and Finland for praise on food labeling, "which has to be easy to understand," she explained.
 
And Chile's Ministry of Agriculture works with a federation of street vendors to provide access to healthy foods in underserved areas and disseminate information on healthy diets.
 
In 2008, the European Union Council of Agriculture introduced a program to provide free fruit and vegetables to school children. A milk program was added in 2017.
 
And in the United States, the Department of Agriculture ran a Healthy Incentives Pilot program in 2011 and 2012 to increase the consumption of fruit, vegetables, and other healthy food among people who rely on a federal subsidy, known as the Supplemental Nutrition Assistance Program (SNAP).
 
People received 30 cents back for every $1 they spent on selected fruit and vegetables, and participants consumed 26% more fruit and vegetables than those who had SNAP benefits but were not given the incentive to buy produce.
 
Meanwhile, examples of places that have tried to make it easier for people to exercise include an Austrian program providing free yoga, Pilates, and fitness classes to people of all ages.
 
And cities such as Copenhagen, London, Amsterdam, Paris, Vienna, and New York have dedicated cycle lanes and bike-sharing programs.
 
Singapore has already banned consumption of anything other than water on public transport, and various other countries have some restrictions, Cecchini said.
 
The Japanese government gives prizes each year for employers that make work environments healthier, and some organizations in the United States and South Africa are advocating the use of standing desks as standard for employees.
 
Each action in and of itself only has a small impact, but it is the combination of them that will make the difference, said Columbo.
 
"There is no room for complacency. We hope next time we are here [in another decade], we will be able to show a decrease in obesity rates," she concluded.
 
The speakers have reported no relevant financial relationships.
https://www.medscape.com/viewarticle/919771#vp_1

Real-World Data Playing a Bigger Role in Drug Development

Changes in the way data are being collected are on track to revolutionize the use of real-world data in drug approvals, Janet Woodcock MD, the longtime director of the FDA’s Center for Drug Evaluation and Research, said here.
“Traditional drug development programs … don’t usually get much insight into who to use a drug in and who not to use a drug in,” Woodcock said Thursday at an event on the future of health data sponsored by Datavant, a company that helps healthcare systems with patient identification. “Are there ways we can capture and utilize the data collected … to make the clinical trial enterprise more effective and efficient?”
The widespread use of electronic health records has drastically improved the availability of health data, she said. With paper charts, individual physicians “had to do archaeological expeditions — literally — to find out what was going on. The same is true of FDA — we used to get tractor-trailers’ worth of paper, literally [to approve drugs] … Now we get data sets that are standardized.” The other big factor “is the digital revolution in general — people have wearables, a lot of people have iPhones, we have telehealth that’s developing. All these things are coming together to provide rich data sources that we can turn into evidence. Our task is to take all the data out there and turn it into something that’s actionable.”
Real-World Data in Use
FDA already has approved numerous supplements and many drugs based on real-world evidence, Woodcock noted. “These are usually for rare conditions, such as male breast cancer, which doesn’t happen very often but is just as devastating as any other cancer. We were able to use evidence generated from use to add that indication to the label.” Using this type of evidence plays into “the long-term vision, articulated quite some time ago by the [National Academies of Sciences, Engineering, and Medicine] as the ‘learning healthcare system’ — that we’re able to make all the information we collect actionable, to assimilate that learning from treating patients and rapidly transform it back into best practices … We’re very, very far from that, but that’s the long-term vision.”
“In the shorter term, what we’re going to see is in terms of drug development and the intervention space and the best practices of delivering healthcare,” she continued. “We’re already generating lots of insights about what’s the best way to do this or that … That will continue to grow.” In addition, data gleaned from wearables and other new technologies will become part of healthcare delivery.
image
Janet Woodcock, MD, FDA Center for Drug Evaluation and Research (Photo by Joyce Frieden)
However, as both the industry and regulators know, “the data out there are not necessarily fit for this purpose right now,” said Woodcock. Take for example, the medical chart of a cancer patient. “What does it say in the chart about cancer? Do you have the right cancer written down? Sometimes, the answer is no. Are the biomarkers in there? Are they entered correctly? That’s important information for the patients … It ought to be right the first time.”
Resisting Standardization
One problem with trying to make data more actionable is that “everyone resists standardization,” she said. “Doctors, especially, want to do things their own way.” She related a story from Peter Bach, MD, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, in New York City, who wanted to have lymphoma care and treatment standardized, so researchers could compare outcomes from different treatments. But some physicians documented their cases differently than the others, so he asked them why and one of them replied, “I don’t agree with the consensus definition of stages of lymphoma. I have my own stages.”
“We need to sell people on the return of that evidence — that if you put something down in a standard way, you’ll get something back,” Woodcock said. However, “it’s an uphill battle. There is much discussion in healthcare circles about what the electronic record is doing to clinicians and to the doctor-patient relationship. It doesn’t have to be that way. That can be fixed, but we’re really going to have to focus on that.”
One problem that crops up with real-world data is that it’s hard to screen out the confounders. “But something we’re exploring is, can you randomize people in your practice and collect real-world outcomes data … without a very elaborate clinical trial apparatus, and can you still get a valid result that’s actionable?” she said.
“We’re collaborating with a lot of groups trying to sort this out — different groups are trying to raise the reliability of that [observational] evidence … Where randomized clinical trials [RCTs] are ongoing, we’re doing a companion observational study, and we’ll see what the results are. We hope to have 20 retrospective ones done by next year, and seven prospective ones. Of course, the real-world study will get done a lot quicker than the RCT … but it will be very interesting to see how they compare and what kind of answers they give.”
Privacy Tradeoffs
The privacy tradeoffs involved in collecting data also are important to think about, said former FDA Commissioner Robert Califf, MD. “In what circumstances do we trade off privacy for the benefit of getting better healthcare? Where are we when health systems advertise the nice doctor in the white coat to cure your disease, when for the most part the doctor is guessing? The guesses are not uneducated guesses, but the fact is whenever we do prospective studies, we find out we’re wrong about half the time, but don’t know which half we’re wrong [or right] about.” For example, take the recent red meat controversy. “Is it OK to eat red meat or not? The data are contradictory because good studies haven’t been done.”
image
Robert Califf, MD, Duke University (Photo by Joyce Frieden)
The use of aspirin to prevent heart attacks is another example, added Califf, who will soon be leaving his position as professor of cardiology at Duke University to work for the Alphabet health subsidiary Verily Life Sciences. Although aspirin has been shown to be effective for secondary prevention, “it’s always bothered me that we don’t know the right dose of aspirin,” he said. “Now we have enrolled over 17,000 people in a randomized trial of baby aspirin versus full-strength aspirin, and we’ll soon know the answer. But this is 140 years after aspirin first went on the market … It’s possible to know a lot more than we know if we just have the discipline to admit uncertainty.”
https://www.medpagetoday.com/publichealthpolicy/fdageneral/82711

Incyte Positive 52-Week Results of Phase 2 Study of Ruxolitinib in Vitiligo

Incyte (Nasdaq:INCY) today announces positive 52-week results from its randomized, double-blind,dose-ranging, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo.
As previously announced, the study met its primary endpoint, demonstrating that significantly more patients treated with ruxolitinib cream for 24 weeks achieved a ≥50 percent improvement from baseline in the facial vitiligo area severity index (F-VASI50)score compared to patients treated with a vehicle control (non-medicated cream).
Updated results at week 52 show substantial improvements in total body repigmentation with ruxolitinib cream, measured by the proportion of patients achieving a ≥50 percent improvement from baseline in the total vitiligo area severity index(T-VASI50),a key secondary endpoint. In addition, after 52 weeks of treatment with ruxolitinib cream 1.5 percent administered twice daily (BID), 58 percent of patients achieved F-VASI50 and 51 percent of patients achieved a ≥75 percent improvement (F-VASI75).F-VASI75 after 24 weeks is the primary outcome measure of both the TRuE-V1 and TRuE-V2 randomized Phase 3 trials that are already underway.
The 52-week results are being shared at the 28th European Academy of Dermatology and Venereology (EADV) congress in Madrid, Spain, during a late-breaking research session today, October 12, 2019, from 11:30 a.m. CEST to 11:45 a.m. CEST (Location: Hall 10 Dalí;Late Breaking News, Abstract #D3T01.1L).
https://www.marketscreener.com/INCYTE-CORPORATION-9675/news/Incyte-Summary-ToggleIncyte-Announces-Positive-52-Week-Results-From-a-Randomized-Phase-2-Study-of-29370591/

Reynolds American files for FDA review of e-cigarette

British American Tobacco Plc unit Reynolds American Inc said on Friday it had filed for a review of its Vuse e-cigarettes by the U.S. Food and Drug administration, giving it a lead over its main rival Juul Labs Inc.
The FDA has set a May 2020 deadline for e-cigarette makers to submit a formal application to keep their products on the market amid its efforts to curb the use of e-cigarette among teens.
Reynolds, whose Vuse e-cigarettes deliver nicotine via a cartridge-based vapor system, said it had provided the health regulator with over 150,000 pages of documentation, including information on the composition, design and manufacturing process associated with its product, as well as safety data.
The company said it had also worked with a team of more than 100 people to prepare the filing, including multiple regulatory experts and scientists.

U.S. regulators are exploring ways to monitor the manufacturing and marketing of e-cigarettes following a rise in use of these products among teens, and a recent outbreak of a mysterious lung illness linked to vaping that has claimed at least 29 lives.
Vaping devices such as Juul’s, which vaporize liquid containing nicotine, have borne the brunt of the regulatory crackdown globally.
The Trump administration also outlined plans in September to remove all flavored e-cigarettes from store shelves, pointing the finger at sweet flavors that had drawn millions of children into nicotine addiction.
https://www.reuters.com/article/us-reynolds-vaping/reynolds-american-files-for-fda-review-of-e-cigarette-idUSKBN1WQ2B1