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Don’t Ignore These Retirement Mistakes. Part-2.

Don’t Ignore These Retirement Mistakes. Part-2.



In Part-1, we explored mistakes investors make due to bad advice, flawed research, and emotional distress.

In Part-2, we continue the journey into a world of COVID and possible economic fallout, much remains unknown. Retirees, and those planning to retire, possess little financial bandwidth for error.

Retirement is not the end of the road. It is the beginning of the open highway.”

Today, retirees face a tremendous challenge: How to generate predictable cash flow with real interest rates on fixed-income investments such as bonds, at zero or negative. As a result, the willingness to take on greater stock market exposure has increased.

Unfortunately, current valuations portend to low future returns for stocks. Furthermore, in the case of a massive correction or bear cycle, older investors don’t have the luxury of time to recover from significant investment losses.

Due to the lingering effects of COVID, retirees are susceptible to unforeseen economic shocks. No longer career-earners, they are unable to replenish investment coffers in the case of adverse events.

If you’re in retirement or planning to be, please consider our Part 2 of the mistakes.

Risk #1: The 4% Portfolio Withdrawal Rule is Full of Nasty Surprises.

At our Right Lane Retirement Class, we discuss how the lifeblood of retirement is a dependable, predictable stream of income. To suggest, investors can consistently withdraw a FIXED percentage every year from VARIABLE portfolio assets such as stocks is borderline fantasy. At the least, it’s unrealistic.

Many retirees should be open-minded to annuities. After all, Social Security is an annuity. Single-premium immediate and deferred products with income riders also provide lifetime guaranteed income. Naturally, stocks can pay dividends, but there’s nothing guaranteed or dependable about them, primarily through times of economic distress.

Bierwith and Bengen Undertake Groundbreaking Research.

In 1994, Larry Bierwith and later William Bengen researched a way for retirees to spend for thirty years with the reasonable assurance their money would last. They modeled a four percent first-year withdrawal followed by inflation-adjusted withdrawals in subsequent years.

Subsequently, a four-percent withdrawal was considered safe as long as a portfolio maintained between fifty and seventy-five percent stocks. Retirees today cannot expect to hold 75% of their portfolios in stocks and adequately sustain bear market losses.

Frankly, with the current Shiller PE at 32X, it’s not practical for even younger investors to maintain an aggressive allocation to stocks unless a strict sell or rebalancing discipline is employed.

Is the 4% Rule Realistic in Today’s Environment?

In a recent interview with ThinkAdvisor, Professor of retirement income at The American College Wade Pfau, weighed in on the topic of withdrawals during the COVID-19 crisis. One of the leading academics in the financial field, Wade believes the stubbornly popular tenet is in peril.

In that interview with Jane Wolman Rusoff dated April 14, 2020, he stated:

I did some updates in mid-March; and for an investor taking a moderate amount of risk, I put out 2.4% as my equivalent of the 4% rule. That’s still about the same today.

Just like that, the holy 4% Withdrawal Rule is cut in half. As of this writing, the stock market has recovered, but that doesn’t mean investor portfolios have followed a similar path.

Keep in mind; academics have questioned the rule for years. In 2008, Jason S. Scott, Nobel-prize winner William F. Sharpe, and John G. Watson revisited it in a paper titled “The 4% Rule – At What Price?”

In the paper, the authors comment:

“We have argued that the major flaw of the 4% is its attempt to support non-volatile spending with volatile investing.”

As a result of a bear market and 20-40% stock losses, how comfortable would you be to stick with the rule? Perhaps you’d reduce future withdrawals to compensate or return to work to prevent further erosion of your nest egg.

A Practical Approach to Portfolio Withdrawals.

Retirees require flexible, customized approaches to portfolio withdrawals. I created general guidelines to jump-start the thought process. Naturally, a strategy should be customized for your situation.

  1. Consider a baseline annual withdrawal rate. A rate you can stick with regardless of portfolio volatility. From experience, I found 2% to be a realistic starting point.
  2. For every 1%, the portfolio increases in value, trim profits, and place the proceeds in cash or spend them (with a modification). For example, let’s say a portfolio increases by 6% for the year. A half-percent for each 1% above the baseline (2%), is 2%. Add the 2% to the base rate to establish a 4% withdrawal rate the following year. Maintain the remaining 2% as a cash buffer for future distribution needs.
  3. With every 1%, the portfolio decreases, limit the following year’s withdrawals to the baseline or plan not to exceed an additional 1%. If losses are 6%, adjust portfolio withdrawals the next year to 3%, or stick with the baseline.
  4. Undergo a distribution checkup every three years. Calculate cumulative net gains minus withdrawals and other costs. In the case of surplus (more gains than withdrawals), by all means, go ahead and spend it. Enjoy. Take that trip. Buy that car. Whatever. Use this time also to assess current trends in inflation, taxes, and fees.

Risk # 2: Retirees: Reset The Inflation Expectation. 

Inflation is unique to each household. An assortment of calculation methods exist; only a few are applied.

Intuitively, inflation should differ for an urban wage earner vs. an older, retired American. The Experimental Consumer Price Index for Americans 62 Years of Age and Older exists for that purpose.

The CPI-E attaches more significant weightings to medical expenses and housing. The share of expenditures on medical care is double that of the CPI-U or W populations. Yet, CPI-E is ignored. Why? Because it would likely result in a budget-prohibitive COLA for Social Security benefits.

Studies show that implementation of CPI-E would result in a 4% greater benefit than currently provided under CPI-W. For that reason, the Social Security Administration uses CPI-W to calculate cost-of-living adjustments for retirement benefits. There’s no reason to believe they’ll change it anytime soon, if ever.

Deflation Now. Inflation Later.

Currently, economic conditions are deflationary. Due to COVID,  I fear imminent price pressures on premiums for healthcare and long-term care costs.

As we age, it’s tough to avoid rising healthcare expenses. Medicare, Medigap, and supplemental Part D Drug Coverage cover a majority of a retiree’s healthcare costs. Even so, inflation has been running close to 6% for Medicare and healthcare insurance premiums. And that’s before COVID.

Also, many retirees are ill-prepared for long-term care expenditures. Generally, long-term care is assistance with activities of daily living like eating and bathing. Medicare does not cover most long-term care costs.

How will Inflation Erode your Retirement?

At RIA, we use an annual inflation factor of 4.5% for additional healthcare expenses (depending on current health of the client), and cost of long-term care. Within three years, I would not be surprised to employ a rate close to or exceeding, 7%.

Inflation is a shapeshifter, a ghost, and on occasion, a boogeyman. Inflation can increase one year, fall the next. It all depends on a household’s unique spending needs.

At RIA, we study inflation trends. As a result, we believe the ongoing cost burden of COVID, along with the rise of global trade barriers and supply chain disruptions, may generate inflationary spikes perhaps not witnessed in over 40 years.

The craft of withdrawals in retirement, along with inflation adjustments, is just as much art as science. Financial plans are as individual as the people who bring the numbers to life!

Financial professionals are sometimes wary of the ‘art’ part, but it doesn’t change the fact that every analysis is a leap of faith. Remember, a financial plan is a comprehensive, educated guess about future outcomes. No plan is perfect.

As a result, a systematic withdrawal strategy requires monitoring and adjustment. COVID inflation is another variable that may impact future cash flow.

Risk #3:  An Emotional Response to Portfolio Positions is Dangerous to Wealth.

In the face of accommodative Central Bank policies, which border on reckless, the emotional state of investors is one of unadulterated greed.

‘Twenty-one-year-old college students think they’re ‘market mavens.” They feverishly trade on platforms such as Robinhood and consider themselves geniuses when the true hero is accommodative monetary policy.

Novice investors conduct little fundamental research and employ narratives, stories, word-of-mouth to buy stocks blindly. The masses are blindly seduced by a Federal Reserve that supports the tailwind in risk assets.

It Bodes a Question: Are Investors Rational? Yes. And No.

A human’s rationality is bounded. Cognitive abilities are limited and emotional biases, plentiful. As a result, few recognize their deficiencies and depend on mental shortcuts to rise above the overload of information.

In a market that only goes higher, investment decisions have become full-on ‘System 1.’ As illustrated in Eugene Higgins Professor of Psychology Emeritus at Princeton, Daniel Kahneman’s bestseller – Thinking Fast, And Slow, human brains operate on two systems.

Consider System 1 the brain on auto-pilot. Fast, emotional, incredibly efficient, but fraught with error. System 2 is the slow, logical, deliberate operator. The one that seeks homework disdains immediate gratification and relishes the long term.

The Fed’ easy cash’ machine has short-circuited our System 2. 

How To Control Your Emotions:

  1. Steer clear of financial television. Financial news is a System 1 overload. Financial news junkies (me included) find it tough to step away from CNBC. Over the years, I’ve learned to be an outsider and a casual observer. I listen to what reporters say and how they say it to understand how a retail investor would interpret the so-called news. It’s fair to watch and generate ideas, but it’s another to trade based on stories blindly.
  2. Establish a PHR. A ‘Personal Hurdle Rate’ is the return necessary to meet financial milestones. An investor with a PHR focuses on the portfolio sufficient return to fulfill goals. Focus is diverted from some arbitrary benchmark like the S&P 500. A holistic financial plan is necessary to determine a PHR. A plan will also help investors understand the portfolio risk taken for a given level of reward.
  3. Avoid the ‘Christmas lights’ investment method. Investors focus on gains and losses tracked in their brokerage accounts. In their minds, winners are green, and losers red. Red and green, just like Christmas lights! To the System 1 brain, green is always good. Red equals bad, but is it? To diversify properly, an astute investor owns investments that react differently to overall market conditions. For example, when the stock market environment is risk-on, bonds go red. Risk-averse conditions cause bonds to go green; stocks go red. Before selling what’s ‘in the red,’ activate your System 2. Do homework, ask questions. Keep in mind, gains and losses do not calculate overall performance or total return. For the most part, the system is designed to help investors get a handle on the tax consequences of liquidation.

The headwind to returns has just begun.

With interest rates lower for longer and stock valuations extended, retiree income remains a challenge. The headwinds have begun. Since early 2018, the RIA planning team has communicated our concerns. Mistakes can make a challenging situation worse.

With objective guidance and planning, you can avoid them.

The post Don’t Ignore These Retirement Mistakes. Part-2. appeared first on RIA.

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Breaking the tape

The top performers among drugs launched in 2020 were each the first of their kind.



Breaking the tape

The top performers among drugs launched in 2020 were each the first of their kind.

By Joshua Slatko •

The leaders in pharma’s Class of 2020 were all firsts. Veklury, for COVID, and Tepezza, for thyroid eye disease, were each the first drug of any kind to be approved by FDA for their respective disease targets. And while other treatments for migraine exist, Ubrelvy was the first orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start. The era of follow-ons in pharma may not entirely be over; but surely the industry’s researchers are still breaking barriers. 

Earning nearly $5.57 billion in sales during the product’s first full calendar year on the market, Veklury was the first drug approved by FDA for the treatment of COVID-19.


The very first drug to be approved in the United States for the treatment of COVID-19, Gilead’s Veklury received emergency use authorization from FDA during May 2020, an expanded EUA three months later, and full approval for treating patients with COVID requiring hospitalization during October 2020. Veklury had originally been developed for the treatment of hepatitis C and had been studied in Ebola and Marburg virus, without success. 

FDA approval was based on three randomized controlled trials including final results of the National Institute of Allergy and Infectious Diseases’ double blind, placebo-controlled Phase III ACTT-1 trial, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19. Based on the strength of these data, Veklury became a standard of care for the treatment of COVID-19 in hospitalized patients.

In the randomized, double-blind, placebo-controlled ACTT-1 trial, Veklury significantly improved time to recovery as compared to placebo – by five days in the overall study population (10 versus 15 days) and seven days in patients who required oxygen support at baseline (11 versus 18 days). As a secondary endpoint, Veklury also reduced disease progression in patients needing oxygen, resulting in a significantly lower incidence of new mechanical ventilation or ECMO (13 percent versus 23 percent). In the overall patient population, there was a trend toward reduced mortality with Veklury compared with placebo at Day 29.

In June 2021, Gilead announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge data for patients treated with Veklury. All three of the real-world analyses observed that, in the overall patient populations, patients who received Veklury treatment had significantly lower risk for mortality compared with matched controls. A reduction in mortality was observed across a spectrum of baseline oxygen requirements. The results were consistently observed at different time frames over the course of the pandemic and across geographies. Two of the studies also observed that patients who received Veklury had a significantly increased likelihood of discharge from the hospital by Day 28.

In January 2022, FDA granted expedited approval of a supplemental new drug application for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. The expanded indication allowed for Veklury to be administered in qualified outpatient settings that can administer daily intravenous infusions over three consecutive days. FDA also expanded the pediatric EUA of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression.

These actions by FDA came amidst a surge in COVID-19 cases and the reduced susceptibility to several anti-SARS-CoV-2 monoclonal antibodies (mAbs) due to the Omicron variant. In contrast, Veklury targets the highly conserved viral RNA polymerase, thereby retaining activity against existing SARS-CoV-2 variants of concern. In vitro laboratory testing has shown that Veklury retains activity against the Omicron variant. 

Quarterly sales, VekluryThe FDA sNDA approval, pediatric EUA expansion, and updated National Institutes of Health Treatment Guidelines for COVID-19 that additionally recommend Veklury for treatment in non-hospitalized settings were based on results from the PINETREE Phase III randomized, double-blind, placebo-controlled trial. The study evaluated the efficacy and safety of a three-day course of Veklury for intravenous use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. An analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, demonstrated that treatment with Veklury resulted in a statistically significant 87 percent reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7 percent, 2/279) compared with placebo (5.3 percent, 15/283). In the study, no deaths were observed in either arm by Day 28.

In February, Gilead released data demonstrating the in vitro activity of Veklury against 10 SARS-CoV-2 variants, including Omicron. Results of Gilead’s studies were consistent with other in vitro studies independently conducted by researchers from institutions in other countries, including Belgium, the Czech Republic, Germany, Poland and the United States, which confirmed Veklury’s antiviral activity against multiple previously identified variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta and Omicron.

The study analyzed in vitro antiviral activity by two methods to understand the susceptibility of 10 major SARS-CoV-2 variants to Veklury. The study results showed similar activity of Veklury against the variants and an early ancestral A lineage isolate detected in Seattle, Wash. (WA1 strain). Specifically, Delta and Omicron variants both remained fully susceptible to Veklury, and these laboratory results demonstrated that Veklury has remained active against all major variants isolated over the past two years.

In April, FDA approved a supplemental new drug application for Veklury for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death. This approval made Veklury the first and only approved treatment for pediatric COVID patients in the United States. Under the expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients who are at high risk for COVID-19 disease progression. For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a five-day treatment course is recommended. The approval was supported by results from the CARAVAN Phase II/III single arm, open-label study, which demonstrated that Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19 with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults.



Tepezza was the first drug ever approved by FDA for the treatment of thyroid eye disease.

When it earned approval in January 2020, Horizon Therapeutics’ Tepezza became the first and only FDA-approved medicine for thyroid eye disease, a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation, and facial disfigurement. Tepezza is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks for a total of eight infusions.

The FDA approval of Tepezza was supported by a robust body of clinical evidence, including statistically significant, positive results from the Phase II clinical study, as well as the Phase III confirmatory clinical study OPTIC. The OPTIC study found that significantly more patients treated with Tepezza (82.9 percent) had a meaningful improvement in proptosis (≥ 2 mm) as compared with placebo patients (9.5 percent) without deterioration in the fellow eye at Week 24. Additional secondary endpoints were also met, including a change from baseline of at least one grade in diplopia (double vision) in 67.9 percent of patients receiving Tepezza compared to 28.6 percent of patients receiving placebo at Week 24. In a related analysis of the Phase II and Phase III clinical studies, there were more patients with complete resolution of diplopia among those treated with Tepezza (53 percent) compared with those treated with placebo (25 percent).

In October 2020, Horizon announced new long-term follow-up data from the Phase II clinical trial of Tepezza, which showed a sustained response up to one year following completion of treatment for thyroid eye disease. All patients with Week 72 data (37/37) reported some improvement in at least one of the study outcomes from baseline. 97 percent (36/37) of study participants had an improvement in clinical activity score (decrease of at least 1 point). 86 percent (31/36) had any decrease in proptosis. One patient chose elective TED surgery at Week 70 and did not have proptosis measurements at Week 72. Of patients with baseline diplopia, 70 percent (23/33) had an improvement of at least one grade. 70 percent (26/37) had disease inactivation (CAS of 0 or 1 point).

During December 2020, Horizon announced that the company expected a short-term disruption in Tepezza supply as a result of government-mandated COVID-19 vaccine production orders related to Operation Warp Speed that dramatically restricted capacity available for the production of Tepezza at its drug product contract manufacturer, Catalent. In March 2021, FDA cleared a prior approval supplement to the previously approved Biologics Licensing Application giving Horizon authorization to manufacture more Tepezza drug product resulting in an increased number of vials with each manufacturing slot. The company began to resupply the market in April, which ended the supply disruption.

Tepezza Quarterly SalesIn April 2021, new pooled data from the Tepezza Phase II and III trials was published in The Lancet Diabetes & Endocrinology. This data further reinforced that Tepezza significantly improves proptosis and diplopia for TED patients in different subgroups, with most maintaining a long-term response. There was no evidence for acute disease rebound (increase in percentage of patients no longer meeting proptosis, diplopia or ophthalmic composite outcome) seven weeks after the last dose of Tepezza. Proptosis (87 percent; 62/71), diplopia (66 percent; 38/58) and ophthalmic composite outcome (92 percent; 66/72) responses were observed seven weeks after the last dose of Tepezza. A post-hoc analysis of the composite ophthalmic outcome indicated that 81 percent (68/84) of Tepezza patients versus 44 percent (38/87) of placebo patients were responders at Week 24. Proptosis (67 percent; 38/57), diplopia (69 percent; 33/48) and composite outcome response (83 percent; 48/58) were observed 51 weeks after the last dose of Tepezza for those who had long-term off-treatment data available.

Additionally, in a post-hoc analysis, Tepezza-treated patients with more severe disease (those with ≥3 mm of proptosis and/or inconstant or constant diplopia) and those with less severe disease at baseline both experienced significant improvements in proptosis and diplopia. In patients with more severe disease, those treated with Tepezza had a proptosis response of 79 percent (50/63) compared to 17 percent (11/65) of those who received placebo, and a diplopia response of 68 percent (38/56) compared to 31 percent of those who received placebo (15/49). In patients with less severe disease, those treated with Tepezza had a proptosis response of 71 percent (15/21) compared to 9 percent in those who received placebo (2/22), and a diplopia response of 80 percent (8/10) compared to 30 percent in placebo (3/10).

In post-hoc analyses, patients who received Tepezza in both the lower baseline CAS subgroup (4 or 5) and the higher CAS subgroup (6 or 7) demonstrated statistically significant improvements compared with placebo in proptosis and diplopia. Overall response and CAS of 0 or 1 response also improved.

Post-hoc analysis from the Phase III study also demonstrated that in patients treated with Tepezza, those with higher (≥10 IU/L) or lower (<10 IU/L) serum thyrotropin-binding inhibitory immunoglobulin (TBII) baseline levels both had a proptosis response (mean reduction of -3.65 mm and -3.01 mm, respectively) with no treatment difference between the two groups. In patients with higher baseline TBII, 71 percent (10/14) of patients who received Tepezza experienced an improvement in diplopia compared to 23 percent (3/13) of patients who received placebo.

In November 2021, Horizon announced findings of a real-world adherence analysis of Tepezza for the treatment of TED. The analysis found that more than 90 percent (n=995) of people who were prescribed Tepezza for TED went on to complete all eight infusions, indicating a high level of adherence to the medicine in clinical practice. The study evaluated 1,101 people living with TED (71 percent female, mean age 58 years) who started treatment with Tepezza prior to July 2020. Non-compliance was low at approximately 1 percent (n=15). Only 8 percent (n=84) reported that they discontinued because of adverse events.

In June 2022, Horizon announced results of a new analysis examining rates of hyperglycemia among patients treated with Tepezza for TED compared to placebo in the Phase II and OPTIC Phase III clinical trials. The analysis found a total of nine adverse event reports of hyperglycemia in eight patients (8/84, 10 percent) who received Tepezza, and one patient (1/86; 1.2 percent) who received placebo. The majority (5/8, 63 percent) of patients who experienced hyperglycemia while taking Tepezza had pre-existing diabetes. Of the hyperglycemic AEs reported in the Tepezza-treated patients, all were controlled with medicine. All reported AEs were grade 1 (>ULN-160mg/dl) or grade 2 (161 – 250mg/dl), and none led to study discontinuation. HbA1c levels increased by 0.22 percent in those treated with Tepezza compared to 0.04 percent among placebo patients.



Ubrelvy was the first orally administered calcitonin gene-related peptide receptor antagonist (gepant) to be approved by FDA for the treatment of migraine attacks once they start.

Approved by FDA in late December of 2019, Ubrelvy was the first orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start. Ubrelvy works by blocking CGRP, a protein that is released during a migraine attack, from binding to its receptors. It works without constricting blood vessels, which some older treatments were known to do. FDA’s approval was based on four clinical studies (ACHIEVE I, ACHIEVE II, UBR-MD-04, and 3110-105-002), which demonstrated efficacy, safety, and tolerability of orally administered Ubrelvy in the acute treatment of migraine. Both 50 mg and100 mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at two hours, compared with placebo. Ubrelvy joined AbbVie’s portfolio when that company completed its acquisition of Allergan in May 2020. 

In August 2020, AbbVie announced Serena Williams as the spokesperson for Ubrelvy to raise awareness of an effective acute treatment option for people living with migraine. The multichannel marketing campaign featuring Williams highlighted how Ubrelvy works for people with different lifestyles by helping individuals treat their migraine attacks anytime, anywhere. As spokesperson, she was featured in a video, available on social media, talking with neurologist and paid AbbVie consultant Dr. Jennifer McVige about her experience with migraine and Ubrelvy. Williams was also included in print and digital advertising and other marketing initiatives.

In September 2021, FDA approved Abb­Vie’s Qulipta, another drug from the gepant family, for the preventive treatment of episodic migraine in adults. Qulipta is the first and only oral calcitonin gene-related peptide receptor antagonist specifically developed for the preventive treatment of migraine. The approval was supported by data from a robust clinical program evaluating the efficacy, safety, and tolerability of Qulipta in nearly 2,000 patients who experienced 4 to 14 migraine days per month, including the pivotal Phase III ADVANCE study, the pivotal Phase IIb/III trial, and the Phase III long-term safety study.

Ubrevly quarterly salesIn the pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial, the primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All Qulipta dose groups met the primary endpoint and demonstrated statistically significant reductions in mean monthly migraine days compared to placebo. Patients treated with 60 mg of Qulipta across 12 weeks experienced a 4.2-day reduction from baseline of 7.8. A key secondary endpoint in the ADVANCE trial measured the proportion of patients that achieved a ≥50 percent reduction in monthly migraine days across the 12-week treatment period. The trial demonstrated that 56 percent/59 percent/61 percent of patients in the 10 mg/30 mg/60 mg Qulipta arms, respectively, achieved a 50-100 percent reduction, compared to 29 percent of patients in the placebo arm.

During June, AbbVie submitted a supplemental NDA to FDA for Qulipta to support the preventive treatment of chronic migraine in adults. If approved, Qulipta would be the first gepant cleared for the broad indication of the preventive treatment of migraine, including episodic and chronic. The supplemental NDA submission includes data from the pivotal Phase III PROGRESS trial in patients with chronic migraine, which supplements the existing data in episodic migraine. People living with chronic migraine experience headaches for 15 or more days per month, which, on at least eight of those days per month, have the features of migraine.

The Phase III PROGRESS trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period in adults with chronic migraine. The trial also demonstrated that treatment with Qulipta 60 mg once daily (QD) and 30 mg daily (BID) resulted in statistically significant improvements in all six secondary endpoints. This includes a key secondary endpoint that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period. 

Josh Slatko, Med Ad News Josh Slatko is contributing editor of Med Ad News and

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Housing Affordability Index Drops To Lowest Rate Since 1989, Still Way Too High

Housing Affordability Index Drops To Lowest Rate Since 1989, Still Way Too High

Authored by Mike Shedlock via,

The National…



Housing Affordability Index Drops To Lowest Rate Since 1989, Still Way Too High

Authored by Mike Shedlock via,

The National Association of Realtors says "affordability" dropped to 98.5 in June, the lowest since 1989.

Housing Affordability Index and mortgage rates via St. Louis Fed.

Affordability in June Was the Worst Since 1989

The Wall Street Journal reports Affordability in June Was the Worst Since 1989

It was more expensive to buy a U.S. home in June than it has been for any month in more than three decades, as record-high home prices collided with a surge in mortgage rates.

The National Association of Realtors’ housing-affordability index, which factors in family incomes, mortgage rates and the sales price for existing single-family homes, fell to 98.5 in June, the association said Friday. That marked the lowest level since June 1989, when the index stood at 98.3.

Housing Affordability Index

The NAR's Housing Affordability Index is based on median income data current  through 2017, projected forward. 

Only 13 months of data is available on Fred, the St. Louis Fed repository.

Affordability is based on whether the median family earns enough income to qualify for a 30-year fixed mortgage loan on the median single-family home without spending more than 25% of the income on payment for principal and interest.

An index value of 100 means that a family with the median income has exactly enough income to qualify for a mortgage on a median-priced home. An index above 100 means a median family has more than enough income to qualify for a mortgage loan on a median-priced home, assuming a 20 percent down payment. 

Inquiring minds may wish to look at the NAR's Housing Affordability Index Calculations.

Curiously, the NAR concludes the median household can nearly always afford the median home price.

Do you believe that? More importantly, even if accurate, so what? 

The median person who can afford a home and wants a home probably already has a home. 

First Time Buyer Index

In terms of new and existing home sales, what matters is what a buyer who does not have a home, but wants a home, is willing to pay and can pay. 

The First-Time Buyer Index for 2022 Q2 fell to 68 assuming a starter home price of $351,500. 

Can 68 percent of would-be buyers afford (and find) a $351,500 home in a neighborhood in which they want to live? 

68 percent is a much more reasonable number than the overall 98.5 percent calculation, but that still strikes me as too high. 

Case-Shiller National Home Price Index

I have not updated my full set of Case-Shiller home price charts for a while but that chart is current (May data). 

Case-Shiller lags by a few months so it's even worse than shown. 

The pre-pandemic index was 212 and it's now 306. That's a 44 percent jump with real median wages declining, property taxes soaring, food soaring, and energy soaring.

Yet, the NAR says that median overall affordability has declined only to the 98.5 percent level. Yeah, right.

Meanwhile, rent and food keep rising and the price of rent will be sticky. Gasoline is more dependent on recession and global supply chains.

Food Prices Rise Most Since February 1979

For more on the price of food, please see Food at Home is Up 13.1 Percent From a Year Ago, Most Since February 1979

For more on rent, please note Tennant's Unions Demand Biden Declare a National Emergency to Stop Rent Gouging

For more on producer prices please see Producer Prices Decline For the First Time Since the Pandemic Due to Energy

Spotlight on Fed Silliness

The Fed has blown three consecutive bubbles trying to produce two percent consumer inflation while openly promoting raging bubbles in assets especially housing.

*  *  *

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Tyler Durden Sun, 08/14/2022 - 12:30

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Summer Teen Employment

Here is a look at the change in teen employment over time.The graph below shows the employment-population ratio for teens (6 to 19 years old) since 1948.The graph is Not Seasonally Adjusted (NSA), to show the seasonal hiring of teenagers during the sum…



Here is a look at the change in teen employment over time.

The graph below shows the employment-population ratio for teens (6 to 19 years old) since 1948.

The graph is Not Seasonally Adjusted (NSA), to show the seasonal hiring of teenagers during the summer.

A few observations:
1) Although teen employment has recovered some since the great recession, overall teen employment had been trending down. This is probably because more people are staying in school (a long term positive for the economy).

2) Teen employment was significantly impacted in 2020 by the pandemic.

Click on graph for larger image.

3) A smaller percentage of teenagers are obtaining summer employment. The seasonal spikes are smaller than in previous decades. 

The teen employment-population ratio was 38.4% in July 2022, down from 38.9% in July 2021. The teen participation rate was 43.6% in July 2022, down from 43.8% the previous July. 

So, a smaller percentage of teenagers are joining the labor force during the summer as compared to previous years. This could be because of fewer employment opportunities, or because teenagers are pursuing other activities during the summer.

3) The decline in teenager participation is one of the reasons the overall participation rate has declined (of course, the retiring baby boomers is the main reason the overall participation rate has declined over the last 20+ years).

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