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Company
‘Somavert’ is reimbursed and starts landing in GHs
by
Eo, Yun-Ho
Sep 01, 2021 05:57am
The new acromegaly drug ‘Somavert’ was listed for insurance benefit and has begun landing in general hospitals. According to industry sources, Pfizer Korea’s Somavert (pegvisomant) has submitted landing applications to drug committees at major medical institutions including the Seoul National University Hospital, Severance Hospital, and Seoul National University Bundang Hospital. As the Severance Hospital at Sinchon treats the most amount of acromegaly patients in Korea, Somavert is expected to be prescribed as soon as it passes the DC review. Somavert’s reimbursement has been approved and will be applied from the next month in September. Somavert was approved in Korea in September last year to treat patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with Somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. The drug demonstrated its efficacy in the randomized, double-blind, pivotal study SEN-3614 that was conducted on 112 acromegaly patients for 12 weeks. The 112 patients were randomly assigned to administer 10mg, 15mg, 20mg of pegvisomant or placebo every day, and its primary efficacy endpoint was the percent change in serum IGF-I concentration from baseline to Week 12. Study results showed that in Week 12, the median serum IGF-I concentration reduction level was 16.8%, 26.7±27.9%, 50.1±26.7%, 62.5±21.3% for the placebo arm, and 10mg, 15mg, 20mg pegvisomant arm, respectively. Pegvisomant significantly reduced serum IGF-I concentrations in all three doses compared to placebo. The rate of patients whose serum IGF-I concentrations normalized compared to baseline were 10%, 54%, 81%, and 89% for the placebo arm and 10mg, 15mg, 20mg pegvisomant arm, respectively. Pegvisomant showed a significantly higher rate in all three doses compared to placebo. Also, pegvisomant significantly improved the overall sign and symptoms of acromegaly in all doses, and the incidence of adverse events was similar for all doses of the pegvisomant and placebo arm. Acromegaly is a rare condition characterized by the excessive secretion of growth hormones that causes abnormal, excessive secretion of IGF-I, and is most often caused by a benign tumor of the pituitary gland. Acromegaly is associated with clinical changes including reduced life expectancy, cardiovascular issues, enlargement of hands, feet and other organs, facial deformity, fatigue, joint pain, metabolic disorder, etc, and may be accompanied by and various secondary systemic complications including osteoarthritis, metabolic complications (insulin resistance, hyperglycemia, hyperlipidemia, etc), risk of neoplasms, hypopituitarism, vertebral fractures, and reduced quality of life. The annual incidence of acromegaly is estimated to be around 3.3 cases per 1 million population, and the worldwide prevalence is about 60 cases per 1 million. Retrospective analysis results that were announced in 2013 for Korea shows that around 1,350 acromegaly patients are registered in 74 secondary and tertiary medical institutions from January 2003 to December 2007, making the annual incidence rate in Korea to be 3.9 cases per 1 million, and prevalence to be 27.9 cases per 1 million in 2007.
Policy
The MOHW objected to improved benefit for Prolia
by
Lee, Jeong-Hwan
Sep 01, 2021 05:57am
The MOHW objected to the criticism that it should continue to apply health insurance benefits of advanced bio-new drug Prolia (Denosumab), which treats osteoporosis, regardless of bone density figures. The MOHW said patients who still have low bone density measurements in follow-up tests after administering osteoporosis treatments such as Prolia continue to recognize their benefits regardless of time. On the 31st, the MOHW responded to a written question about the benefit standards for osteoporosis drugs by Rep. Lee Jong-sung, People Power Party. Rep. Lee requested that the standard for osteoporosis treatments be changed to improve Prolia's benefit regardless of bone density levels. Improving the benefit standard for osteoporosis treatments has continued to be needed by domestic medical staff and medicine experts. The benefit standard is to stop paying for osteoporosis patients if their bone density levels, T-score, are improved to "2.5 or less" due to the use of treatments earned by them. Osteoporosis drugs, which have already earned salaries, are converted to non-salary based on patient bone density figures. Previously, bisphosphonate drugs, which are used once a day, were mainly prescribed for osteoporosis treatment, but recently, Prolia prescriptions, which are injected once a six-month period, are mainly used. Rep. Lee also agreed with the request and asked the MOHW about its willingness to improve it, but it gave a theoretical answer that it would review it in accordance with the principle of standards. In particular, if bone density levels are still low in patient follow-up tests, Prolia's benefit continues to be recognized regardless of the period of time. "Prolia has expanded its primary treatment pay in 2019," it said. The MOHW also said, "The duration of administration of osteoporosis drugs depends on the measurement of bone density and whether or not osteoporosis fractures occur. Patients with low measurements in follow-up tests continue to pay Prolia." "We have continuously expanded the benefit standards for osteoporosis drugs by referring to textbooks, guidelines, and academic opinions," it added. "We will consider the principles of insurance benefits such as clinical usefulness, cost effectiveness, and required finance."
Policy
Lucentis biosimilars have been applied to the MFDS
by
Lee, Tak-Sun
Sep 01, 2021 05:57am
Along with Chong Kun Dang, Samsung Bioepis also applied for permission to the MFDS for Lucentis biosimilar. Lucentis (Ranibizumab) is a treatment for ophthalmic diseases that treat macular degeneration and various eye damage, and it is a blockbuster with annual global sales reaching ₩4.6 trillion and sales of ₩37 billion in Korea as of last year. According to the MFDS on the 31st, Lucentis biosimilar, a candidate from Chong Kun Dang and Samsung Bioepis, has received an application for permission. Chong Kun Dang announced to the media that it applied for permission for items on the 28th of last month. The company explained that from September 2018 to March this year, 25 hospitals, including Seoul National University Hospital, conducted the clinical phase 3 of Lucentis biosimilar candidate "CKD-701" for 312 macular degeneration patients. Macular degeneration can lead to blindness if the macula, a tissue that accepts light from the retina, loses its function or becomes severe due to aging and inflammation. Chong Kun Dang said it confirmed that there were no statistically significant differences in drug efficacy and other pharmacokinetics, immunogenicity and safety in indicators of less than 15 letters of vision loss and improved vision, average changes in maximum calibration vision, and thickness of the central retina. Samsung Bioepis also completed its domestic clinical trial for Lucentis Biosimilar candidate "SB11 shares" and applied for permission from the MFDS. Samsung Bioepis proved its equivalence with the original drug in phase 3 of the multinational market for 705 people. From March 2018 to December 2019, clinical equivalence and validation criteria were met through comparative studies between SB11 and Lucentis in clinical trials of a total of 705 wet age-related macular degeneration (nAMD) patients. In August, the company received approval for the first Lucentis biosimilar product in Europe. In November last year, the U.S. FDA began reviewing permits. The Korean patent for Lucentis ended in April 2018. As a result, biosimilar can enter the market as soon as it is approved. If the two companies start selling their products around the same time, fierce competition is expected.
Policy
DREC to include patient and civic groups' recommendations
by
Lee, Hye-Kyung
Sep 01, 2021 05:57am
In addition to experts recommended by consumer groups, experts recommended by patients and civic groups will also be included in the 8th Drug Reimbursement Evaluation Committee (DREC) that will be commissioned next month. Also, detailed guidelines that did not exist before for DREC’s subcommittees were newly established to aid the organization and smooth operation of subcommittees. The National Health Insurance Review and Assessment Service (HIRA) had recently finalized the ‘partial amendment to the operating regulations for DREC’ that contained the abovementioned changes. The amendment was made to improve fairness, objectivity, and transparency in the operations of DREC and its subcommittees. The new and changed provisions include: ▲Adding civic groups as a recommending body for DREC members (Article 3-1), ▲New regulations on the organization and operation of subcommittees (Article 6-2), and ▲ Clarification of terms to be observed by DREC members including the obligation to report and avoid unfair solicitation (mandatory provision) (Article 16-1), etc. The provision that stipulated recommending bodies for DREC members to ‘consumer organizations (including patient groups)’ was specified to include consumer, patient, and civic groups. With the increased number of recommending bodies, the 8th DREC member pool increased from 99 to 102. New operation guidelines on the specific organization and operation were newly established for DREC’s subcommittees that were operated for the effective evaluation of eligibility for medical insurance benefits, etc (reimbursement standards, PE evaluations, RSA, fiscal impact assessment, herbal medicine, post-evaluation), to be consistent with the subcommittee guidelines set for similar committees such as the Professional Review Committee. DREC's subcommittees are composed of 6-7 members including one chairperson, one or more clinical experts recommended by medical and pharmaceutical societies, and one or more experts with expertise and experience in health insurance and drug benefit evaluations. Agendas in subcommittees are passed with attendance by a majority of members and a majority vote. Also, reports of solicitation, which was a voluntary provision, was amended to a mandatory provision. Also, the existing provision that stipulates that members can apply for evasion to the chairperson for reasons of unfair solicitation, has been changed to “must apply for evasion.” If the Committee chair (or director) who received the evasion application believe that the fairness, objectivity of the member cannot be trusted for an agenda, the chair may reject attendant or opinion of the member, and collect opinions from other members on the agenda to remove the agenda from the plate or withhold discussions for a period set by the committee.
Company
Sales of PARP inhibitor Zejula surpassed Lynparza in 2 years
by
Sep 01, 2021 05:56am
PARP inhibitor Zejula (Niraparib tosylate monohydrate) outpaced its competitor Lynparza (Olaparib) in about 2 years. According to IQVIA, a pharmaceutical market research firm on the 31st, Zejula, Takeda's ovarian cancer treatment drug, recorded ₩3.5 billion in sales in the second quarter, surpassing Lynparza, which recorded ₩3.4 billion. Zejula, which started its first sales in the fourth quarter of 2019, started to grow rapidly in December 2020. Sales jumped from around ₩1 billion last year to ₩3.2 billion in the first quarter of this year. In the second quarter, it increased by 289% year-on-year to ₩3.5 billion. In the first quarter of last year, AstraZeneca's Lynparza, which previously dominated the market, showed ₩2.3 billion, ₩2.9 billion, ₩3.3 billion and ₩3.7 billion, respectively, but sales in the second quarter fell slightly to ₩3.4 billion. Zejula is also estimated to be ahead of Linpaza in the number of patients. As a result of converting the adjusted daily average number of pills into sales, Zejula was prescribed 34,900 days, Lynparza capsule and Lynparza tablet were prescribed 18,900 days and 7,700 days, respectively, in the second quarter. Lynparza and Zejula are both competing fiercely for ovarian cancer treatments before the PARP inhibition. Lynparza was approved in 2015. Zejula received a domestic permit in March 2019, much later than this, but it was applied to the secondary treatment in December 2020. Zejula outpaced Lynparza. This is because Lynparza and Zejula have concluded drug price negotiations with the NHIS over the expansion of primary maintenance benefits for ovarian cancer. The benefit range will be expanded together through the Health Insurance Policy Committee next month. Although the scope of ovarian cancer primary therapy indications for both products is expanded for Zejula, which can be used regardless of BRCA mutation, insurance benefits apply under the same conditions. This is because the HIRA Cancer Drugs Benefit Appraisal Committee recognized clinical usefulness only for BRCA training. Therefore, the two products are expected to compete from October when benefits are expanded.
Company
GS Cross’s Neulapeg sales jump fivefold in 3 years
by
An, Kyung-Jin
Aug 31, 2021 06:14am
The locally developed neutropenia treatment ‘Neulapeg’ is enjoying its belated prime. The drug, which was unable to make a presence earlier at the time of its release is continuing to break new records every quarter since signing a sales partnership with Boryung Pharmaceuticals. Neulapeg’s quarterly sales have risen over fivefold in the past 3 years, and are attempting to overtake the market leader position held by ‘Nelasta.’ According to the pharmaceutical market research institution IQVIA, sales of GC Cross’s ‘Neulapeg’ increased 64.8% YoY to reach ₩5.4 billion in Q2. Compared to Q2 2018, quarterly sales of the product increased over fivefold. ‘Neulapeg’ is a neutropenia treatment made with pegfilgrastim that was developed with GC Cross’s original technology. The drug is used on cancer patients during chemotherapy to prevent side effects of decreasing immunity that occur from a decrease in the neutrophil level. It received marketing authorization from the Ministry of Food and Drug Safety in August 2014 and began its sale in March of the next year. ‘Neulapeg’ applies the PEGylation technology that conjugates polyethyleneglycol to specific areas to improve the purity, stability, and half-life of the drug over existing therapies. Neulapeg is considered a 2nd generation drug as may be administered only once per chemotherapy cycle to see an effect compared to existing neutropenia treatments that are administered 4-6 times per cycle. Despite its strength of being nearly ₩300,000 cheaper than Kyowa Kirin’s ‘Neulasta(pegfilgrastim),’ Newlapeg wasn’t able to make much of a presence earlier at the time of its release. In its third year, 2017, Neulapeg had sold ₩3.2 billion, and then ₩4 billion in 2018. Quarterly sales of Neulapeg, which was less than ₩1 billion, started to soar after Boryung Pharmaceutical joined in as a sales and marketing partner with GC cross. In Q4 2018, its sales jumped from ₩1.1 billion to 1.3 billion in the following quarter, 1Q 2019, and then continued upwards ever since. GC Cross had signed a joint sales agreement for ‘Neulapeg’ with Boryung Pharmaceuticals in October 2018. GC Cross had attempted to work with Boryung and utilize the company’s sales capability in the field of anticancer to expand its share in the neutropenia treatment market. According to IQVIA, Neulapeg accumulated sales of ₩8.9 billion in 2019. This is a 123.4% growth in sales in just one year after its partnership with Boryung Pharmaceuticals. Last year, despite the spread of the COVID-19 pandemic, it increased its market share by twofold and raised ₩15 billion in sales. This is a fourfold expansion in annual sales compared to 2018, before signing a partnership with Boryung Pharmaceuticals. And the company is continuing to make new records, earning ₩4.9 billion in Q1, and ₩5.4 billion in Q2. Cumulative sales in 1H of this year were ₩10.2 billion, a 62.8% increase from the previous year. On the other hand, Neulasta sold ₩12.3 billion, a 0.2% decrease from the previous year. This has narrowed the gap between the two products to ₩2.2 billion. If this trend continues, experts believe the position of the two products may be reversed within this year. On the other hand, Dong-A ST’s neutropenia treatment ‘Dulastin, which was released at a similar period as GC Cross’s Neulasta, has still been unable to mark a presence in the market. Dulastin sold ₩1.5 billion in 1H this year. Until 2018, the drug had made sales similar to Neurapeg. However, due to Neurapeg’s sudden and rapid growth in sales, the sales gap has widened to around 7 times. Dong-a ST had received marketing authorization for Dulastin in August 2014, and has started selling it in March of the following year. Dulastin is a second-generation G-CSF derivative that was applied to the company’s own extended-release technology for longer action. Its extended-release technology allows for the drug to stay in the blood for a longer period of time, which allows patients to administer the drug only once per chemotherapy cycle. ‘Lonquex (lipegfilgrastim),’ another second-generation neutropenia treatment that was released in 2016, is also not seen much sales for many years. Longquex sold ₩1.5 billion in 1H this year. This was a 6.2% YOY increase. Lonquex is a molecular structurally improved G-CSF that was developed by applying Handok Teva’s unique PEGylation technology. It is also administered once per chemotherapy cycle.
Policy
MFDS requests supplements for porcine islet transplant trial
by
Lee, Tak-Sun
Aug 31, 2021 06:14am
Experts from the Ministry of Food and Drug Safety expressed the opinion that supplementary data is necessary for the clinical trial protocol studying a xenotransplantation product that transplants islet cells isolated from pigs to diabetic patients. With such an opinion issued, it seems that some time would be required before the clinical trial of a xenotransplantation product is conducted. The trial had gained much attention as being the ‘world’s first’ trial on a xenotransplantation product. On the 30th, the Ministry of Food and Drug Safety disclosed the results of the Central Pharmaceutical Affairs Council (CPAC)’s ‘Advisory meeting on the feasibility of the submitted investigator-led clinical trial on a xenotransplantation product’ that was held on the 13th on its webpage. The clinical trial aimed to transplant an islet cell extracted from a pig to a diabetes patient to verify its effect. A trial testing porcine pancreatic islet cells that secrete insulin on monkeys had confirmed the long-term antidiabetic effect of such transplantation, increasing the potential for its effect in humans. However, the CPAC requested data supplementation, saying that a more detailed plan is required for human trials. One committee member who attended the meeting said, “Despite the efforts stated to educate patients on the self-use of Continuous Glucose Monitoring Systems and self-monitoring, the trial subjects need to be clarified to patients who were objectively verified to have low ability to recognize hypoglycemia (develop hypoglycemic coma). I believe the clinical trial may be approved on the premise that the supplementations are made according to the results of the meeting.” Another member said, “Unlike animal studies, a clearer standard and evidence on selecting appropriate subjects and on the safety would be needed for human xenotransplantation studies, considering the risk and safety issues of humans who would need take immunosuppressants for the rest of their life. As of now, the results are not sufficient to recommend trial commencement.” Another member emphasized, “The blood test results alone cannot ensure safety from infection in humans, especially regarding positive porcine endogenous retroviruses (PERVs). Due to negative opinions on the clinical trial commencement, the Central Pharmaceutical Affairs Council collectively determined that supplementary data would be required for the protocol. The CPAC delivered the opinion that the registration criteria and scope should be clarified, and sufficient quality assessment and non-clinical data (cell survival and distribution, etc) that includes evidence on the safety of porcine pancreatic islet cells (PERV, latent infection, etc.) needs to be submitted. Due to this, the world’s first clinical trial using porcine pancreatic islet cells will not be approved soon. In August last year, the Seoul National University’s Xenotransplantation Research Center, Gachon University Gill Medical Center, and GenNBio had submitted an application for an investigator-led clinical trial that transplants a pancreatic islet cell of a gnotobiotic pig to diabetes patients.
Company
Dong-A strengthens line-up with Sanofi's Actonel sales
by
Aug 31, 2021 06:13am
Dong-A ST is expected to create synergy with its item Teribone by taking charge of the sale of Sanofi's osteoporosis treatment, Actonel. Dong-A ST will supply Sanofi-Aventis' osteoporosis treatment, Actonel, starting in October. Actonel is a bisphosphonate-based treatment that inhibits bone absorption. Since its launch in 2003, it has ranked 1st and 2nd in market share, but the amount of prescription has been gradually decreasing due to the emergence of new drugs and changes in treatment strategies. It has been out of stock due to issues such as relocation of manufacturing plants. Sanofi stopped supplying Actonel 5mg due to low sales in April, and stopped supplying Actonel 35mg this month. There are Actonel 5mg, 35mg, 150mg and Actonel EC 35mg. Dong-A ST will continue supplying Actonel that Sanofi gave up. Dong-A ST is planning to resupply Actonel from October after changing permission. Dong-A ST is selling Teribone, a bone formation promoter introduced by a Japanese pharmaceutical company. Although it made ₩260 billion in sales in Japan as of 2014, it is not up to ₩2 billion in Korea. Dong-A ST analyzed that Actonel and Teribone will create synergy effects. Although a remarkable new drug has recently been released, bisphonate preparation is still a standard treatment option. "We expect good synergy with the bone absorption inhibitor Actonel and the bone formation promoter Teribone," a company official said.
Policy
There is a need to apply the HPV vaccine NIP Men Under 17
by
Lee, Jeong-Hwan
Aug 31, 2021 06:13am
President Moon promises free vaccination for girls under 12 → girls under 17. In addition, there is a need for free vaccination of male teenagers of the same age group. HPV, which causes cervical cancer, claims that the country needs to expand vaccination because it can infect both men and women through sexual contact and causes various diseases such as men's penile cancer, anus cancer, and mouth cancer. Recently, President Moon promised to expand the national vaccination age range of the cervical cancer vaccine Gardasil 9 to women under the age of 17. This means the expansion of Gardasil 9's NIP coverage. The possibility of additional benefit for men under 17 years of age is checked for the effectiveness and side effects of Gardasil 9. The application of the HPV vaccine to men under the age of 17 was necessary when Choi Hye-young, a member of the Democratic Party of Korea, proposed some revisions to the Act on the Prevention and Management of Infectious Diseases in November last year. Representative Choi Hye-young's proposal includes expanding the mandatory vaccination age range for HPV vaccines from "girls under 12" to "all children and adolescents under 18." Cervical cancer is the only cancer vaccinated against 99% or more. However, the vaccination price reached up to ₩600,000, making it difficult to expand the vaccination rate. HPV vaccines are rapidly expanding from vaccinations for women only in the past to those for both men and women today. In fact, the WHO, the ACS, and the NCI have announced plans to raise the vaccination rate of HPV to 80% for young men and women aged 13 to 15. The CDC ACIP and the IPVS are also recommending vaccinations for girls and boys aged 11 to 12. In addition, 40 out of 113 countries in the world that have confirmed the HPV vaccine are supporting the expansion of male vaccinations. Other countries that support vaccination include the United States, Canada, Australia, New Zealand, Switzerland, Italy and Austria. In addition, 35 out of 36 OECD countries introduced HPV vaccine as a national vaccination, and more than half of them expanded their vaccination targets to South Korea. Choi, who proposed the bill, was pleased with President Moon's promise to expand the age of HPV vaccinations, but expressed regret that male teenagers under the age of 17 are not included. Some criticize that most female teenagers under the age of 17 who fall within the national prevention range of HPV vaccine have already received free vaccination benefits from the designation of the NIP in 2016, which is not effective. This is why some point out that free vaccination should be carried out not only for women under the age of 17 but also for men of the same age to increase the effectiveness of NIP. An official from the domestic pharmaceutical industry said, "It will take years for President Moon to expand the application of HPV vaccine NIP." He said, "HPV disease is increasing the prevalence rate of men, so the government should consider a policy to include male adolescents in the scope of NIP." Rep. Choi Hye-young said, "I would like to express my deep appreciation for President Moon's direct response. Cervical cancer is the only cancer that can be prevented by vaccination. However, the free vaccination target was limited to 12-year-old girls, which was not effective enough." She added, "We will conduct legislative activities focusing on the infection prevention law, which has been proposed, including the issue of boys being excluded from the free vaccination list for cervical cancer."
Company
A lawsuit is scheduled to be filed against the price system
by
Nho, Byung Chul
Aug 30, 2021 05:55am
It is expected that a number of domestic and foreign pharmaceutical companies will file an administrative lawsuit to defend the lowering of the drug price due to the change in the drug price system. Due to the revaluation of the drug price system, 475 items will be reduced in batches starting next month, and the annual economic loss of pharmaceutical companies is estimated to be up to 90 billion won. According to the industry, some domestic and foreign pharmaceutical companies are discussing specific measures with large law firms to cope with the loss of drug prices due to changes in the drug price system. A multinational pharmaceutical company is said to have filed an administrative lawsuit against the MOHW or the HIRA through law firm A to respond to the revision of the additional reassessment, which is scheduled to take effect on the 1st of next month. The pharmaceutical company wants to sue the MOHW because it is ineffective to apply for mediation due to all economic losses since the additional system has already been abolished. In the supply negotiations between the NHIS and pharmaceutical companies, there is a provision that fines will be imposed if the supply of the drug is not smooth due to the drug reduction. Many legal experts say, "Even if there is no immediate disposition, the requirements of administrative litigation will be met if economic disadvantages and rights infringement are certain in the future." In particular, the legal community said that there is a possibility of suspension of execution and winning the lawsuit against the original bill. The industry reported the purpose of the lawsuit that ▲ Violation of trust protection principles under the Administrative Act ▲ Significant loss of sales occurred due to the drug reduction, which was linked to a reasonable interpretation. There was a precedent in which the administrative court accepted the suspension of execution of pharmaceutical companies, citing the regulation under the Administrative Procedure Act that "Trust in administrative actions implemented by administrative agencies should be maintained and protected." In addition, clear evidence data of applicants due to drug reductions are expected to play an important role. 70% of originals, 68% of generic and raw materials, and 59.5% of generics have been applied to the system. If the generic is first registered, it will be given a pharmaceutical product for the first year, and if the pharmaceutical company produces the same ingredient product less than three companies, it will be able to maintain the additional product without limitation until more than four companies are registered. The additional period of this month's notice is limited to three years, and the HIRA's judgment extends up to two times a year, effectively up to five years. It seems to be due to the superficial interpretation that "the risk of supply has been extinguished due to the stable supply of medicines for 10 years after the system was implemented." However, the reason for the stable supply of the drug to date was because of the preservation of the drug price. The smooth supply of drugs correlates with drug prices and cost rates. "This revision notice could interfere with the stable supply of medicines," said an official of company A, who is considering a lawsuit. "IThe use of guidelines to cut drug prices up to the relatively low-cost line can be a good alternative so as not to commit the right to lose the opportunity to treat the public."
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