how much does sotrovimab cost uk . 7 Therapeutic Goods Administration (TGA), Australia under provisional approval on January 20, 2022. 2. FDA has authorized the emergency use of sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The most common treatment-emergent adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care. As such, we are actively preparing approximately 55,000 doses of sotrovimab for immediate allocation to your jurisdictions. The UK has already started rolling out an antibody cocktail to treat Covid called Ronapreve that was co-developed by Roche and Regeneron. [11] On November 30, 2022, the FDA announced that bebtelovimab isnt currently authorized in any U.S. region because it isnt expected to neutralize Omicron sub-variants BQ.1 and BQ.1.1. The most recent research from the CDC suggests that protection from the Pfizer and Moderna COVID-19 vaccines starts to fade around 4 months after a booster dose. The report assessed Pfizer Inc's (PFE.N) Paxlovid and Merck & Co's (MRK.N) molnupiravir - both recently authorized antiviral pills - as well as sotrovimab, an intravenous monoclonal antibody drug developed by GlaxoSmithKline Plc (GSK.L) and Vir Biotechnology Inc (VIR.O). Researchers from the University of Minnesota applied in December for emergency authorization of fluvoxamine for high-risk COVID patients after studies showed that the anti-depressant, which also has anti-inflammatory properties, reduced hospitalization rates by 32%. ICER plans to accept public comment on its draft and issue an updated evidence report in late March. The base cost of each medicine is set by the manufacturer. For sotrovimab For intravenous infusion (Xevudy), dilute in 50 mL or 100 mL Glucose 5% or Sodium Chloride 0.9% and administer over 30 minutes through an in-line 0.2 micron filter. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Greg Abbott announced Tuesday that had tested postiive for Covid-19, his office shared that he was treated with a therapy not yet approved by the US Food and Drug . The patient or parent/caregiver has the option to accept or refuse sotrovimab. Important Information About Sotrovimab. There can be variation in the licensing of different medicines containing the same drug. June 7, 2022 . In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID19. how much does sotrovimab cost uk. Sotrovimab is under review by UK regulators. The recommended dosage of Sotrovimab to treat mild-to-moderate COVID-19 infection in patients is 500 mg. People who test COVID positive should start Sotrovimab treatment immediately for. website belongs to an official government organization in the United States. Sotrovimab is given one time by injection into a vein by a health care professional. Mechanism: Sotrovimab is a recombinant human IgG1-kappa mAb that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2 with a dissociation constant KD = 0.21 nM) but does not compete with human ACE2 receptor binding (IC50 value >33.6 nM [5 g/mL]). That leaves one COVID-19 treatment available to treat omicron infections, and in early December, GlaxoSmithKline (GSK) announced that its sotrovimab monoclonal antibody "retains in vitro . Use only if potential benefit outweighs riskno information available. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Therefore, sotrovimab is not authorized for use in adults and pediatric patients who are hospitalized due to COVID19, OR who require oxygen therapy and/or respiratory support due to COVID19, OR who require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 in those patients on chronic oxygen. Sign up to get the latest information about your choice of CMS topics. Please review our, You need to be a subscriber to join the conversation. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. We do not sell or distribute actual drugs. Limitations of Benefit and Potential for Risk in Patients with Severe COVID19. The cost of Regeneron's two-drug cocktail is $1,250 per infusion, according to Kaiser Health News. Important: When there is a range of pricing, consumers should normally expect to pay the lower price. Sotrovimab is a new anti-viral therapy that has been approved for use on patients aged 12 years or more with severe attack of COVID-19. Xevudy (sotrovimab) was approved for the following therapeutic use: Xevudy has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death (see Section 5.1 . When Texas Gov. View medicinal form and pricinginformation. There are now some 25 Anti-SARS-CoV-2 mAbs currently at various stages of clinical development (The Antibody Society 2021). 08 May. (MHRA), UK on November 4, 2021. "Right now the alignment of the price and benefits look reasonable," ICER President Steve Pearson told Reuters. But until further evidence shows it's effective, the guidelines say it should only be given to patients as part of a human clinical trial. . Vir was pulled down by the overall stock market sell-off earlier this week. More than 4.8 million persons worldwide have died from coronavirus disease 2019 (Covid-19) during the global pandemic. For providers and suppliers with payments that are geographically adjusted by the methodology used by the Medicare Physician Fee Schedule (MPFS), files with the geographically adjusted payment rates for monoclonal antibody administration are included in the Additional Resources section below. lock For patients who meet the criteria for repeat dosing, the authorized dosage is an initial dose of 1200 mg, followed by subsequent repeat dosing of 600 mg once every 4 weeks for the duration of ongoing exposure. Meanwhile . You will then need to be monitored for around 30 minutes after the infusion is complete. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Store in a refrigerator (28) and protect from lightconsult product literature about storage after dilution. How much does it cost? Providers and suppliers should use Q0245 and M0245 or M0246 to bill for administering bamlanivimab and etesevimab for PEP. Sotrovimab is an engineered human immunoglobulin monoclonal antibody that binds to the spike protein receptor binding domain of SARS-CoV-2, which prevents the virus from entering human cells. [6] On October 12, 2022, the FDA authorized the Moderna bivalent product (dark blue cap with gray border) and its administration for use as a single booster dose in individuals 12 years through 17 years of age in addition to the 8/31/2022 FDA authorization as a single booster dose in individuals 18 years and older. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of sotrovimab. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. Certain settings utilize other payment methodologies, such as payment based on reasonable costs. ICER also analyzed the cost-effectiveness of fluvoxamine, a 40-year-old generic pill used to treat conditions such as obsessive-compulsive disorder and depression at a cost of about $10 for a 10-day course. About SotrovimabSotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. ) [2]These rates will also be geographically adjusted for many providers. FACT SHEET FOR US HEALTHCARE PROVIDERS (ENGLISH), FACT SHEET FOR US HEALTHCARE PROVIDERS (SPANISH), FACT SHEET - HEALTHCARE PROVIDERS (ENGLISH), FACT SHEET - HEALTHCARE PROVIDERS (SPANISH), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs, Fact Sheet for Patients, Parents, and Caregivers, Fact Sheet for Patients, Parents, and Caregivers (English), Fact Sheet for Patients, Parents, and Caregivers (Spanish), https://www.fda.gov/media/149534/download, https://www.fda.gov/media/149533/download, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html, Sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency [see. HCPCS Q0249, M0249 and M0250 are billable on TOB 12X (inpatient hospital only). Page last reviewed: 20 December 2021. It can also be administered to pediatric patients over 12 years of age and weighing at least 40 kgs. Share sensitive information only on official, secure websites. There are currently no Patient Assistance Programs that we know about for this drug. NICE expects to publish its final recommendations on medicines to treat COVID-19 in March 2023. Valid at all major chains including Walgreens, CVS Pharmacy, Target, WalMart Pharmacy, Sotrovimab is authorized for use under an Emergency Use Authorization (EUA), so there is no dispute, and it is for "the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at . As of Sunday, there are 1138 Covid-19 patients in hospital across the ACT, NSW, Victoria, Queensland, South Australia and the NT. Of the estimated 2 million people with long covid, 1.4 million are thought to have been infected, or suspect they were infected, at least 12 weeks prior to their ongoing symptoms. There are limited clinical data available for sotrovimab. There are limited clinical data available for sotrovimab. FDA has authorized the emergency use of sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. It can also be administered to pediatric patients over 12 years of age and weighing at least 40 kgs. Words such as may, will, plan, potential, aim, promising and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. [1]Since we anticipate that providers, initially, will not incur a cost for the product, CMS will update the payment allowance at a later date. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the US Securities and Exchange Commission, including the section titled Risk Factors contained therein. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with its partners. Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (eg, pre-syncope, syncope), dizziness, and diaphoresis. Were the sotrovimab . It is the second Covid-19 treatment to receive regulatory approval in Australia, following the TGA's . You'll only need 1 dose. GSK is not responsible for content on third-party websites. Giving the medicine this way means it can be given at the right rate - not too fast and not too slow. Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration. The government has ordered 7,700 doses of sotrovimab. 1. Merck's COVID treatment drug, molnupiravir, has only passed the first hurdle towards approval in Australia but the federal government has bought 300,000 doses after some promising preliminary results. Vir routinely posts information that may be important to investors on its website. CMS has released a set of toolkits for providers, states and insurers to help the health care system prepare and assist in swiftly administering these products once they become available. Eligibility requirements vary for each program. limited the authorized use of the Janssen COVID-19 vaccine. (tixagevimab co-packaged with cilgavimab): Part B Biosimilar Biological Product Payment and Required Modifiers. GlaxoSmithKline Plc has delivered some good news amid mounting concerns about the omicron variant. Trademarks are owned by or licensed to the GSK group of companies. It was carefully selected for its demonstrated promise in preclinical research and potential ability to both block the virus from entering healthy cells and clear infected cells. The cost for sotrovimab intravenous solution (500 mg/8 mL) is around $2,221 for a supply of 8 milliliters, depending on the pharmacy you visit. Infusion-related reactions, including immediate hypersensitivity reactions, were observed in subjects treated with sotrovimab in COMET-ICE (1%) and in COMET-TAIL (<1%). Find out more, Markets approach mini-Budget madness levels ahead of Hunt's Spring Statement, How Tesco and Sainsbury's obsession with Aldi fuelled Britain's fruit and vegetable rationing crisis, British chipmakers hold talks with White House amid Biden charm offensive, Germany and Italy block Brussels from banning petrol and diesel cars, Students to be allowed to use ChatGPT for GCSE and A-level exams under Whitehall plans, Covid antibody treatment from GlaxoSmithKline. However, due to stock shortages and other unknown variables we cannot provide any guarantee. means youve safely connected to the .gov website. Walkin' Blues Son House Instruments, [6]On July 30, 2021, the FDA revised the EUA for casirivimab and imdevimab to allow its use for post-exposure prophylaxis (PEP) in certain adult and pediatric patients. Issued: London, UK and San Francisco, US. In addition, please provide a copy of all FDA MedWatch forms to: GlaxoSmithKline, Global Safety; Fax: 919-287-2902; Email: WW.GSKAEReportingUS@gsk.com; Or call the GSK COVID Contact Center at 1-866-GSK-COVID (866-475-2684) to report adverse events. She said as the world moved into the endemic phase, vaccines and treatments would need to work in a complementary fashion. Pseudotyped virus-like particle neutralization data of Sotrovimab (May 2021) B.1.1.7 (UK origin): No change: less than 5-fold reduction in susceptibility; B.1.351 (South . This drug is authorized for adults and kids over 12 years old. . The three treatments - approved on an emergency basis for people with mild-to-moderate COVID-19 deemed at risk of progressing to serious illness - have been purchased by the U.S. government and are being distributed free-of-charge to healthcare providers. + Large molecular weight suggests limited excretion into milk. Between 30 June and 13 July, 6,175 patients in the UAE received sotrovimab. what is the bench press for nba combine? Sotrovimab for Early Covid-19. Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of sotrovimab. There are no available data on the presence of sotrovimab in human milk, the effects on the breastfed infant, or the effects on milk production. The patients are typically monitored for another hour afterwards for allergic reactions. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. The federal government is covering the cost of the monoclonal antibody therapies, so it is free to get, but . The U.S. government has paid around $530 for a 5-day course of Paxlovid, $700 per five-day course of molnupiravir, and $2,100 for a course of sotrovimab - the lone available antibody treatment . The GSK treatment could also be used to protect a "cohort of the population who, for medical reasons, cannot mount an appropriate immune response to vaccination or, for whatever reason, do not get vaccinated and are also at higher risk of hospitalisation or death". When omicron becomes dominant, it is expected to wipe out or weaken much of the covid-19 medicine cabinet, putting the focus on sotrovimab, which is an intravenous infusion from Vir Biotechnology . For more information, review the COVID-19 provider toolkit. The five patients who subsequently needed intensive care were all from the placebo group. To enroll, go to https://covid-pr.pregistry.com or call 1-800-616-3791 to obtain information about the registry. GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Commission (EC) has granted marketing authorisation to Xevudy (sotrovimab) for the early treatment of COVID-19.Sotrovimab is now approved in the European Union (EU) for the treatment of adults and adolescents . One reaction led to temporary pausing of the infusion. You are leaving the GSK sotrovimab site to visit a separate website. Sotrovimab (Xevudy) Brand name: Xevudy. That leaves one COVID-19 treatment available to treat omicron infections, and in early December, GlaxoSmithKline (GSK) announced that its sotrovimab monoclonal antibody "retains in vitro . discounted medicines and copay programs to low income or uninsured and under-insured people who meet specific guidelines. In an attempt to study the safety and effectiveness of sotrovimab in more vulnerable patients suffering from mild to moderate symptoms of COVID-19, a multinational team of researchers conducted . Treatment involves a one-hour intravenous infusion of 500 mg of sotrovimab, said Chagla. It may be used in some circumstances but Paxlovid, remdesivir and molnupiravir are usually used instead. The treatment has yet to be approved by UK regulators but has been given the green light in the US, the EU and Japan. Here are 10 ways to save money on prescription drugs, Paxlovid, molnupiravir, remdesivir, Actemra, Lagevrio, nirmatrelvir / ritonavir. The free Drugs.com Discount Card works like a coupon and can save you up to These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. The Government said there was a "critical, urgent need to procure and deploy a new class of monoclonal antibodies (mAbs) that can neutralise any Covid-19 variant". [9] On January 24, 2022, the FDA announced that, due to the high frequency of the Omicron variant, REGEN-COV (casirivimab and imdevimab, administered together) isnt currently authorized in any U.S region. Final draft guidance based on cost effectiveness evaluation of sotrovimab. All rights reserved. . Patients treated with sotrovimab should continue to self-isolate and use infection control measures (eg, wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. Early in vitro data suggests sotrovimab retains activity against the Omicron variant. Sotrovimab, sold under the brand name Xevudy, is a human neutralizing monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2. Payment Allowances and Effective Dates for COVID-19 Monoclonal Antibodies and their Administration During the Public Health Emergency: EVUSHELD isnt currently authorized for emergency use in the U.S. Jan - Dec 2022 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP). state of decay 2 best facilities; yahoo google google; nc attorney general office. It's called sotrovimab, and scientists say preliminary checks suggest it should work well . . NHS England Interim Clinical Commissioning Policy: Antivirals or neutralising monoclonal antibodies for non-hospitalised patients with COVID-19 (available at: https://www.england.nhs.uk/coronavirus/publication/interim-clinical-commissioning-policy-neutralising-monoclonal-antibodies-or-antivirals-for-non-hospitalised-patients-with-covid-19/). 2022 GSK or licensor. Sotrovimab is administered at a dose of 500 mg. Secure .gov websites use HTTPSA [3]Johnson & Johnson COVID-19 vaccine. Another COVID-19 treatment, Xevudy (sotrovimab), has today been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing . Of those patients, 291 received Sotrovimab, while the remaining 292 had a placebo. For providers and suppliers with payments that are geographically adjusted by the methodology used by the Medicare Physician Fee Schedule (MPFS), files with the geographically adjusted payment rates for COVID-19 vaccine administration are included in the Additional Resources section below. HCPCS Q0220, M0220, and M0221 billable on the following TOBs: 12X, 13X, 22X, 23X, 34X, 72X, 75X, 81X, 82X and 85X. GlaxoSmithKline on Thursday said that a pre-clinical analysis of the antibody-based COVID-19 has indicated that the drug also works against the new Omicron variant. 01:56. Next review due: 20 December 2024. To learn more about COVID-19, visit the CDC and WHO websites. [4]On April 16, 2021, the FDA revoked the EUA that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. With the mass-production of recombinant mAbs now capable of meeting demand, and at a cost that is competitive with other treatments (Taylor 2021), this line of potential therapy has generated much interest amongst developers. It was carefully selected for its demonstrated promise in preclinical research and potential ability to both. Due to these data, use of sotrovimab is not authorized in any U.S. state or territory at this time, as indicated in the FDA Fact Sheet for Healthcare Providers. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. is executive career partners legitimate - bighorn mountains weather - how much does sotrovimab cost uk; 8 jun, 2022 We welcome the final draft guidance from NICE which we believe is particularly meaningful as the organizations recommendations are informed by independent committees that aim to provide guidance to healthcare professionals on the best care options available to benefit their patients, said George Scangos, Ph.D., Chief Executive Officer of Vir. In the last few weeks, the agency had been limiting the use of sotrovimab in a growing number of regions as cases from the subvariant spread. As such, we are actively preparing approximately 55,000 doses of sotrovimab for immediate allocation to your jurisdictions. This price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies. dababy white teeth Uncategorized how much does sotrovimab cost uk. minnesota wild vs colorado avalanche prediction; north tyneside council envirolink; smartview2 system menu pin; high speed gear handcuff taco kydex; how much does sotrovimab cost uk. An interim analysis reported that COVID-19 had progressed in 3/291 patients infused with sotrovimab and 21/292 given a placebo. Medicare Part B Payment for COVID-19 Vaccines and Certain Monoclonal Antibodies during the Public Health Emergency. SOTWCNT220036 May 2022 Produced in USA. Please see the FDA Letter of Authorization , Fact Sheet for Healthcare Providers , Fact Sheet for Patients, Parents, and Caregivers (English) , and Fact Sheet for Patients, Parents, and Caregivers (Spanish). It is vitally important that, alongside vaccines, we have treatments available that can help stop progression to severe disease in patients at high risk from the infection.". QUICK TAKE Sotrovimab for Early Covid-19 01:56. how much does sotrovimab cost uk. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab monoclonal antibody (MAB) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing . is a member of the miscellaneous antivirals drug class and is commonly used for increased risk for progression to severe COVID-19. It is administered as a single dose through a drip in the arm (infusion) for more than 30 minutes. Both Pfizer and Moderna upped European prices for their products this year; the EU will now pay $23.15 per dose of Pfizer's jab (up from $18.40), while Moderna is charging $25.50 for doses that previously cost around $22.60. This bulletin was updated on Jan. 6, 2022 in COVID-19 Bulletin #208.. Sotrovimab, with the brand name Xevudy, is the second. Vir Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Treatment began within five days of the start of symptoms. If you got the product for free, and your systems require a product code to bill for the administration, enter $0.01 for the billed amount. What Is Sotrovimab? If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. The UK medicines regulator has just approved a new COVID-19 treatment. Sotrovimab is not FDA-approved and is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. REGEN-COV has a list price of about $1,250 per dose, while sotrovimab is more than $2,000 per dose, although Regeneron's product is free to patients as the bill is paid by the federal government. Sotrovimab Vir 7831 is an investigational single-dose monoclonal antibody for the treatment of mild-to-moderate COVID-19 in adults. There is a 10-day window to get the treatment after symptom onset, according to the Centers for . south bend fire department news. 2 Living guideline Last December the UK's Medicines and Healthcare Products Regulatory Agency approved sotrovimab for people aged over 12 with mild to moderate covid-19 who were at high risk of developing severe disease, after it was shown to reduce the risk of hospital admission and death by 79% in high risk adults with symptomatic covid-19. On top of that, we add a fee to cover the cost of our services, enabling us to continue functioning as a social enterprise. UK approves GSK's Covid antibody drug that slashes risk of . All quotes delayed a minimum of 15 minutes. The deal is subject to approval. Protection against COVID-19 hospital stays drops from 91% soon after receiving a booster dose to 78% at the 4-month mark. The Department for Health and Social Care has bought 100,000 doses of the treatment, called sotrovimab, which has yet to be approved by UK regulators but has been given the green light in the.
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