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Top 15 Best-Selling Drugs Launched in 2020

The additional challenges to launching new drugs that emerged since COVID-19 upended the biopharma industry, and life as we knew it, will continue into 2021. Yet the challenging environment for drug development has not stopped companies from launching…

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The additional challenges to launching new drugs that emerged since COVID-19 upended the biopharma industry, and life as we knew it, will continue into 2021, according to the annual list of trends released December 21 by Seqens CDMO North America (formerly PCI Synthesis, a contract development and manufacturing organization focused on producing new chemical entities (NCEs), active pharmaceutical ingredients (APIs), and other specialty chemical products.

Those challenges, according to Segens CDMO NA, include supply chain issues that require companies to find alternative sources for raw materials; and the potential for shortages of medicines due to biopharmas diverting raw materials and manufacturing capacity to producing COVID-19 drugs and vaccines. More than 300 such therapeutics are in development, according to GEN’s COVID-19 DRUG & VACCINE TRACKER.

And despite the demand by politicians across the political divide for lower prices, drug prices will likely rise, Segens CDMO NA predicted. It offered reasons extending beyond possible drug shortages and the ongoing cost of developing new medicines, including the many layers of drug delivery partners that add costs without adding value.

“Companies and regulators need to make long-term systemic changes to ensure the U.S. and the world can be better positioned to handle potential disruption from a future pandemic,” Ed Price, founder of Seqens CDMO NA, said in a statement. “This will include finding new ways to protect supply chains and streamline processes to more easily work with regulators and get faster approvals while ensuring patient safety.”

Yet the challenging environment for drug development has not stopped companies from launching dozens of new treatments.  The FDA, for example, approved no fewer than 52 novel drug approvals during 2020  as of December 21—already surpassing the 48 approvals issued in 2019, though just under the 59 approvals granted in 2018.

Below is GEN’s top 15 A-List of top-selling prescription drugs launched in 2020, based on sales data disclosed by the drugs’ developers through the first three quarters.

Top-selling drugs are ranked based on sales or revenue reported for the first through third quarters of 2020 by biopharma companies in press announcements, annual reports, investor materials, and/or conference calls. Each drug is listed by name, reported sales, sponsor(s), type, and diseases for which the treatment is indicated.

Ranking #20 through #16 in Q1-Q3 2020 were treatments that generated between CHF 7 million (about $7.9 million) and $11.875 million—Enspryng (satralizumab-mwge) and Evrysdi (risdiplam), both from Genentech, a Member of the Roche Group; Intra-Cellular Therapies’ Caplyta (lumateperone); GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf), and Incyte’s Pemazyre® (pemigatinib).

Nearly half (seven) of the top 15 drugs launched in 2020 as of deadline were indicated for various forms of cancer—with two of the therapeutics launched as treatments for gastrointestinal stromal tumors (GIST). Two top-selling newly launched drugs listed below are indicated for migraines (as was a third drug that generated too little in sales to make the list, Lundbeck’s Vyepti [eptinezumab-jjmr]), which made only DKK 42 million (about $6.9 million).

Another two top selling drugs were indicated for blood disorders. And as might be expected during the pandemic, another two of the top 15 best-selling newly launched drugs were indicated as treatments for COVID-19.

Not included on the list were drugs for which data was unavailable for any of several reasons: In some cases, a drug’s developer was privately held and did not disclose any sales information. In other cases, a publicly-traded developer of a newly-launched drug limited its sales disclosures to its top-selling therapeutics. Still in other cases, the launch of a drug came during the fourth quarter, with data to emerge only when the company reports fourth quarter results in 2021.

 
15

Ayvakit(avapritinib)

Q1-Q3 2020 sales: $15.3 million

Sponsor(s): Blueprint Medicines

Type: Tyrosine kinase inhibitor targeting PDGFRA and PDGFRA D842 mutants as well as multiple KIT exon 11, 11/17 and 17 mutants with half maximal inhibitory concentrations (IC50s) less than 25 nM

Indication(s): Unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations, in adults

FDA Approval Date: January 9, 2020

14

Retevmo(selpercatinib)

Q1-Q3 2020 sales: $17.9 million

Sponsor(s): Eli Lilly

Type: Kinase inhibitor targeting wild-type RET and multiple mutated RET isoforms as well as VEGFR1 and VEGFR3 with IC50 values ranging from 0.92 nM to 67.8 nM

Indication(s): Forms of non-small cell lung cancer (adults); medullary thyroid cancer and other types of thyroid cancers (patients aged 12 years and older) whose tumors have a mutation or fusion in the RET (rearranged during transfection) gene

FDA Approval Date: May 8, 2020

13

Tabrecta(capmatinib)

Q1-Q3 2020 sales: $18 million

Sponsor(s): Novartis

Type: Kinase inhibitor targeting MET, including the mutant variant produced by exon 14 skipping

Indication(s): Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test

FDA Approval Date: May 6, 2020

12

Qinlock® (ripretinib)

Q1-Q3 2020 sales: $20.0 million

Sponsor(s): Deciphera Pharmaceuticals

Type: Tyrosine kinase inhibitor targeting KIT proto-oncogene receptor tyrosine kinase (KIT) and platelet derived growth factor receptor A (PDGFRA) kinase, including wild type, primary, and secondary mutations

Indication(s): Treatment of adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib

FDA Approval Date: May 15, 2020

11

Sarclisa® (isatuximab-irfc)

Q1-Q3 2020 sales: €18 million ($21.999 million)

Sponsor(s): Sanofi

Type: CD38-directed cytolytic antibody

Indication(s): Multiple myeloma in adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and dexamethasone

FDA Approval Date: March 2, 2020

10

Nurtec ODT (rimegepant)

Q1-Q3 2020 sales: $28.513 million

Sponsor(s): Biohaven Pharmaceuticals

Type: Calcitonin gene-related peptide receptor antagonist

Indication(s): Acute treatment of migraine with or without aura in adults

FDA Approval Date: February 27, 2020

9

Zepzelca(lurbinectedin)

Q1-Q3 2020 sales: $36.9 million

Sponsor(s): Jazz Pharmaceuticals

Type: Alkylating drug designed to bind guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove

Indication(s): Treatment of adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy

FDA Approval Date: June 15, 2020

8

REGEN-COV2 (casirivimab and imdevimab)

Q1-Q3 2020 sales: $40.2 million

Sponsor(s): Regeneron Pharmaceuticals

Type: Combination or “cocktail” of two monoclonal antibodies

Indication(s): Treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization

FDA Approval Date: November 21, 2020

7

Ubrelvy® (ubrogepant)

Q1-Q3 2020 sales: $60 million

Sponsor(s): AbbVie 1

Type: Calcitonin gene-related peptide receptor antagonist

Indication(s): Acute treatment of migraine with or without aura in adults

FDA Approval Date: December 23, 2019

6

Adakveo® (crizanlizumab-tmca)

Q1-Q3 2020 sales: $71 million

Sponsor(s): Novartis

Type: Selectin blocker

Indication(s): Reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease

FDA Approval Date: November 15, 2019

5

Trodelvy(sacituzumab govitecan-hziy)

Q1-Q3 2020 sales: $73.0 million

Sponsor(s): Immunomedics (Acquisition by Gilead Sciences completed on October 23)

Type: Trop-2-directed antibody and topoisomerase inhibitor conjugate

Indication(s): Treatment of adults with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease (Approved under accelerated approval)

FDA Approval Date: April 22, 2020

4

Ruxience(rituximab-pvvr)

Q1-Q3 2020 sales: $78 million

Sponsor(s): Pfizer

Type: CD20-directed cytolytic antibody; biosimilar to Rituxan® (rituximab), co-marketed by Genentech and Biogen

Indication(s): Non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis), and microscopic polyangiitis when taken in combination with glucocorticoids (all in adults)

FDA Approval Date: July 23, 2019

3

Reblozyl® (luspatercept-aamt)

Q1-Q3 2020 sales: $159 million

Sponsor(s): Bristol-Myers Squibb (BMS) and Acceleron Pharma 2

Type: Erythroid maturation agent

Indication(s): Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions; Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)

FDA Approval Date: November 8, 2019

2

Tepezza® (teprotumumab-trbw)

Q1-Q3 2020 sales: $476.3 million

Sponsor(s): Horizon Therapeutics

Type: Insulin-like growth factor-1 receptor inhibitor

Indication(s): Thyroid Eye Disease

FDA Approval Date: January 21, 2020

1

Veklury® (remdesivir)

Q1-Q3 2020 sales: $873 million

Sponsor(s): Gilead Sciences

Type: SARS-CoV-2 nucleotide analog RNA polymerase inhibitor

Indication(s): Adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization 3

FDA Approval Date: October 22, 2020

 

References
1. Ubrelvy was developed by Allergan, which was acquired by AbbVie for $63 billion in a deal completed May 8, 2020.
2. Reblozyl was developed by Celgene and Acceleron. BMS acquired Celgene for $74 billion, in a deal completed November 20.
3. In its “Prescribing Information” label, Gilead states that Veklury “should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.”

The post Top 15 Best-Selling Drugs Launched in 2020 appeared first on GEN - Genetic Engineering and Biotechnology News.

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GDP Slows Sharply in Third Quarter Due to Supply Chain Pressures

Service consumption rose at a 7.9 percent rate, despite the delta variant.
The post GDP Slows Sharply in Third Quarter Due to Supply Chain Pressures appeared first on Center for Economic and Policy Research.

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Service consumption rose at a 7.9 percent rate, despite the delta variant.

GDP grew at just a 2.0 percent annual rate in the third quarter as supply chain issues hampered growth in several key areas. Durable goods consumption contracted at a 26.2 percent annual rate, knocking 2.7 percentage points off the quarter’s growth. Equipment investment fell at a 3.2 percent annual rate, while housing construction dropped at a 7.7 percent annual rate, knocking 0.18 percentage points and 0.38 percentage points off the quarter’s growth, respectively.

Even with Third-Quarter Declines, Vehicle Consumption Is Still Far Above Pre-Pandemic Levels

The drop in third-quarter car sales accounted for 2.39 percentage points of the hit to GDP from durables. However, car sales are still 4.3 percent above the year-round average for 2020. This means that the supply chain problems are stemming from extraordinary demand, which will fade in the quarters ahead, not an inability to supply a normal quantity of vehicles.

Housing Is Also Above Pre-Pandemic Levels, In Spite of Third Quarter Decline

Even with the 7.7 percent drop in housing construction, which followed a drop of 11.7 percent in the second quarter, output in the sector was still more than 10 percent above the 2019 average. It will likely remain somewhere near the current level in future quarters, after jumping sharply due to low interest rates at the start of the pandemic.

Consumption of Services Grew at a 7.9 Percent Annual Rate in the Quarter

In spite of concerns about the spread of the delta variant, services grew at a solid 7.9 percent annual rate following growth of 11.5 percent in the second quarter. However, service consumption is still 1.6 percent below its pre-pandemic level. Recreation services and transportation, which is largely commuting expenses, account for the bulk of this drop. The category of food services and accommodations rose at a 12.4 percent annual rate in the quarter (in spite of delta) adding 0.54 percentage points to growth. Real restaurant sales are actually above pre-pandemic levels.

Inventories Added 2.07 Percentage Points to GDP in the Third Quarter

This was all due to growth in non-farm inventories, which added 2.14 percentage points to growth. Farm inventories continued a fall that began in the third quarter of 2015. The drop in non-farm inventories presumably is the result of both relatively low prices over this period and weather conditions. It is important to realize that inventories still declined at a $77.7 billion annual rate in the third quarter, but this was still a positive for GDP since it was much slower than the $168.5 billion rate of decline in the second quarter. As inventories stop shrinking and start to rebuild, they will be a big positive for growth in future quarters. 

Nonresidential Investment Grew at a 1.8 Percent Annual Rate

Declines in equipment investment and structures largely offset an increase of 12.2 percent in investment in intellectual products. The rise in investment in intellectual products was the fourth consecutive double-digit increase. The 3.2 percent decline in equipment investment is likely due to supply chain problems, as it had been growing at double-digit rates for the last four quarters and orders remain high. The drop in structure investment is due to less demand for office and retail space, which is likely to be a permanent feature of the post-pandemic world.

Trade Deficit Subtracts 1.14 Percentage Points from Growth

A rise in the trade deficit, due to a 2.5 percent drop in exports and a 6.1 percent rise in imports, slowed growth by 1.14 percentage points in the quarter. The rise in imports was all on the service side, which rose at a 44.4 percent annual rate. This was largely US travel abroad, which was up more than 50 percent from the second quarter rate but still less than 60 percent of pre-pandemic level. Foreign travel in the US fell slightly in the quarter and is still just over 30 percent of pre-pandemic levels.

Saving Rate Remains Above Pre-Pandemic Levels

The saving rate was 8.9 percent in the quarter, which is well above the 7.5 percent average for the three years before the pandemic. This means that we are still not seeing the story pushed by inflation hawks that people would be spending down the savings they had accumulated during the period where large sectors of the economy were shut down, and they were getting the pandemic checks from the government.

Inflation and the Path Forward

The core Personal Consumption Expenditure (PCE) rose at a 4.5 percent annual rate in the third quarter, down from 6.1 percent in the second quarter. We are likely to see further slowing inflation as the supply chain problems get resolved in the quarters ahead. Shipping costs will be leveling off, so they will no longer be adding to inflation, and then dropping. It is important to recognize that the profit share of income rose sharply in the last two quarters, which means that rising prices have not been driven by higher labor costs.

CEPR produces same-day analyses of government data on inflation, employment, GDP and other topics.
Follow @DeanBaker13 on Twitter to get his quick-take analysis of government data immediately upon release.

The post GDP Slows Sharply in Third Quarter Due to Supply Chain Pressures appeared first on Center for Economic and Policy Research.

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ECB Leaves Policy Unchanged (As Expected), Will Keep Buying Bonds Until At Least March 2022

ECB Leaves Policy Unchanged (As Expected), Will Keep Buying Bonds Until At Least March 2022

With global bond markets starting to ‘tantrum’ at the short-end, and price-in policy-errors at the long-end, traders are hoping for soothing words…

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ECB Leaves Policy Unchanged (As Expected), Will Keep Buying Bonds Until At Least March 2022

With global bond markets starting to 'tantrum' at the short-end, and price-in policy-errors at the long-end, traders are hoping for soothing words from ECB's Christine Lagarde this morning as the market has shifted notably more hawkish for European rates, pricing in a full rate-hike by the end of 2022 (due to mounting inflation expectations)...

Source: Bloomberg

While no change in policy is expected in the ECB's statement, or a decision on the APP/PEPP's taper timeline (expected in December), so all eyes will be on how (or if) The ECB attempts to shift the market's far more hawkish views on rates than the monetary policy-setters project.

The hawkish market pricing is “hard to reconcile with our view of ECB coming on the dovish side today,” said Piet Christiansen, chief strategist at Danske Bank.

And as expected, The ECB makes no major changes in the policy statement.

Officials reiterated they will continue bond buying at a “moderately lower pace”, and that the pandemic program will run until at least the end of next March.

The Governing Council will continue to conduct net asset purchases under the PEPP with a total envelope of €1,850 billion until at least the end of March 2022 and, in any case, until it judges that the coronavirus crisis phase is over.

The full redline shows very little change in the statement:

Now all eyes back to Lagarde and her press conference at 0830ET for more dovish leanings on rates. So far, she has made it clear that the bank considers the higher prices to be temporary and said the bank won't “overreact” by easing its efforts to keep interest rates low for businesses, governments and consumers. She is expected to argue that the economy still needs extensive support.

*  *  *

Full Statement below:

The Governing Council continues to judge that favourable financing conditions can be maintained with a moderately lower pace of net asset purchases under the pandemic emergency purchase programme (PEPP) than in the second and third quarters of this year.

The Governing Council also confirmed its other measures, namely the level of the key ECB interest rates, its forward guidance on their likely future evolution, its purchases under the asset purchase programme (APP), its reinvestment policies and its longer-term refinancing operations. Specifically:

Key ECB interest rates

The interest rate on the main refinancing operations and the interest rates on the marginal lending facility and the deposit facility will remain unchanged at 0.00%, 0.25% and -0.50% respectively.

In support of its symmetric two per cent inflation target and in line with its monetary policy strategy, the Governing Council expects the key ECB interest rates to remain at their present or lower levels until it sees inflation reaching two per cent well ahead of the end of its projection horizon and durably for the rest of the projection horizon, and it judges that realised progress in underlying inflation is sufficiently advanced to be consistent with inflation stabilising at two per cent over the medium term. This may also imply a transitory period in which inflation is moderately above target.

Asset purchase programme (APP)

Net purchases under the APP will continue at a monthly pace of €20 billion. The Governing Council continues to expect monthly net asset purchases under the APP to run for as long as necessary to reinforce the accommodative impact of its policy rates, and to end shortly before it starts raising the key ECB interest rates.

The Governing Council also intends to continue reinvesting, in full, the principal payments from maturing securities purchased under the APP for an extended period of time past the date when it starts raising the key ECB interest rates and, in any case, for as long as necessary to maintain favourable liquidity conditions and an ample degree of monetary accommodation.

Pandemic emergency purchase programme (PEPP)

The Governing Council will continue to conduct net asset purchases under the PEPP with a total envelope of €1,850 billion until at least the end of March 2022 and, in any case, until it judges that the coronavirus crisis phase is over.

The Governing Council continues to judge that favourable financing conditions can be maintained with a moderately lower pace of net asset purchases under the PEPP than in the second and third quarters of this year.

The Governing Council will purchase flexibly according to market conditions and with a view to preventing a tightening of financing conditions that is inconsistent with countering the downward impact of the pandemic on the projected path of inflation. In addition, the flexibility of purchases over time, across asset classes and among jurisdictions will continue to support the smooth transmission of monetary policy. If favourable financing conditions can be maintained with asset purchase flows that do not exhaust the envelope over the net purchase horizon of the PEPP, the envelope need not be used in full. Equally, the envelope can be recalibrated if required to maintain favourable financing conditions to help counter the negative pandemic shock to the path of inflation.

The Governing Council will continue to reinvest the principal payments from maturing securities purchased under the PEPP until at least the end of 2023. In any case, the future roll-off of the PEPP portfolio will be managed to avoid interference with the appropriate monetary policy stance.

Refinancing operations

The Governing Council will continue to provide ample liquidity through its refinancing operations. In particular, the third series of targeted longer-term refinancing operations (TLTRO III) remains an attractive source of funding for banks, supporting bank lending to firms and households.

***

The Governing Council stands ready to adjust all of its instruments, as appropriate, to ensure that inflation stabilises at its two per cent target over the medium term.

 

 

 

 

Tyler Durden Thu, 10/28/2021 - 07:52

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NYC Firefighters Union Tells Members To Defy Vaccine Mandate; NYPD Union Loses Bid To Halt

NYC Firefighters Union Tells Members To Defy Vaccine Mandate; NYPD Union Loses Bid To Halt

Members of New York’s finest are pushing back against Covid-19 vaccine mandates to the point of civil disobedience.

On Wednesday, the head of the…

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NYC Firefighters Union Tells Members To Defy Vaccine Mandate; NYPD Union Loses Bid To Halt

Members of New York's finest are pushing back against Covid-19 vaccine mandates to the point of civil disobedience.

On Wednesday, the head of the New York City firefighters union said that he told unvaccinated members to report for duty regardless of an order from Mayor Bill de Blasio threatening to place them on unpaid leave if they refuse to take the jab, according to Reuters.

"I have told my members that if they choose to remain unvaccinated, they must still report for duty," said Andrew Ansbro, president of the Uniformed Firefighters Association. "If they are told they cannot work, it will be the department and city of New York that sends them home. And it will be the department and the city of New York that has failed to protect the citizens of New York," he added.

According to Ansbro, firefighters who have put their lives on the line during the pandemic feel "insulted" by de Blasio's order, and New Yorkers will be the ones to suffer if the mayor carries out his threat.

"Fires are going to burn longer. Heart attack victims are going to be laying on the floor longer," Ansbro told Fox News Radio.

"People in stuck elevators are going to be stuck there for hours if not days." (h/t Summit News)

Ansbro also predicted that 30 to 40% of firehouses in NYC will be closed down if the mandate remains, as up to 45% of the workforce remains unvaccinated.

"On Friday, when they’re tallying the numbers of who complied and who didn’t, they’re going to be faced with a stark reality that they’re going to have to close firehouses down," he said, adding "The mayor is going to be faced with either sending us home or sticking to his guns,” Ansbro continued, adding “And his guns are going to get New York City residents killed."

NYPD loses bid to halt mandate

Meanwhile, a Staten Island Judge denied the Police Benevolent Association's bid to temporarily halt the implementation of the city's vaccine mandate set to take effect Nov. 1, according to CBS News.

The largest police union in the city had argued that de Blasio's policy does not make clear their policy on potential exceptions, including for medical or religious reasons, and does not allow unvaccinated cops enough time to apply for said potential exemptions - which were required to be submitted just one week after the mandate was announced.

"Today's ruling sets the city up for a real crisis. The haphazard rollout of this mandate has created chaos in the NYPD," said PBA President Patrick J. Lynch in a statement. "City Hall has given no reason that a vaccine mandate with a weekly testing option is no longer enough to protect police officers and the public, especially while the number of COVID-19 cases continues to fall."

The union plans to appeal, calling the mandate "arbitrary and capricious" in court documents.

The policy requires police officers, firefighters and other municipal workers get at least their first dose of the COVID-19 vaccine by Friday or be placed on unpaid leave. Correctional officers on Rikers Island — a New York City prison that has been grappling with staffing shortages and unsafe conditions — will be subject to the mandate on December 1.

The NYPD's vaccination rate has lagged behind the rest of the city — as of Tuesday, the NYPD's vaccination rate is 73%, compared with the 78.2% of adults who have been vaccinated in New York City. The PBA, which represents over 24,000 current NYPD officers, contends that getting the vaccine is a personal medical decision.

The NYPD has about 36,000 officers and about 19,000 civilian staff employees. -CBS News

We noticed nobody's leading with the natural immunity argument, considering that thousands of NYPD officers have recovered from Covid-19.

Watch the latest video at foxnews.com
Tyler Durden Thu, 10/28/2021 - 11:14

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