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- 2026-05-17 04:00:30
- Policy
- Bill to stop reimbursement of drugs upon disposition
- by Lee, Jeong-Hwan Feb 11, 2022 05:55am
- A bill to immediately stop prescriptions of pharmaceuticals that have received sales suspension dispositions due to expedient acts such as rebates at hospitals and clinics is being pushed for legislation. If enacted, the bill will immediately suspend reimbursement of pharmaceuticals that will receive administrative dispositions and stop hospitals and clinics from prescribing such pharmaceuticals. On the 10th, NA member Byung-Won Kang of the Democratic Party of Korea submitted a bill for the partial amendment of the Medical Service Act that contains the changes above. Kang pointed out the issue of continued prescriptions from hospitals and clinics for drugs that receive manufacturing and sales suspension dispositions. In such cases, the drugs that are suspended from sales continue to be prescribed at hospitals and clinics, resulting in shortages in the supply of such drugs during the disposition period. Kang claims that this issue needs to be promptly addressed. Due to continued prescriptions of such drugs, frontline pharmacies need to work to preemptively secure inventory of the drugs when an administrative disposition or sales suspension is imminent, which leads to a sales increase for the pharmaceutical company while the inconvenience and confusion caused by the disposition are passed on to pharmacies and patients. This is why the pharmacists’ community has been voicing that an actual sanction must be imposed on companies that receive administrative dispositions to maximize the prevention of recurrent acts. To address this need, Kang submitted the bill to immediately suspend reimbursement of pharmaceuticals that are confirmed to receive administrative dispositions and stop hospitals and clinics from prescribing such pharmaceuticals during the disposition period. Kang said, “The bill will suspend reimbursement of drugs and allow doctors and dentists to check if the drugs are suspended from sales if they receive administrative dispositions due to rebates to stop prescriptions. The bill will improve the unreasonable structure where the sales of drugs that have received administrative dispositions surge in a short term and minimize the damage borne by pharmacies and patients."
- Company
- Prodrug for Forxiga patent dispute ruling has been postponed
- by Kim, Jin-Gu Feb 11, 2022 05:55am
- Forxiga The second trial ruling on the patent dispute between Dong-A ST and AstraZeneca over Forxiga, a diabetes treatment based on SGLT-2 inhibitors, has been postponed. The Patent Court's 5-2 Court postponed the date of the judgment on the trial decision cancellation suit filed by AstraZeneca against Dong-A ST from the 10th to the 17th. The court seems to have been worried in that it was the first case in Korea to try to overcome material patents using a "prodrug" strategy. Prodrug is evaluated as a different drug, such as an original drug. The original drug and chemical structure differ in some parts of the substituent until immediately before taking it after the drug is produced. However, when a patient enters the body after taking it, it has the same effect as the original drug. In terms of principle alone, it is similar to salt change, but the difference is clear. The salt can be converted into a simple ionic bond. The chemical structure of the substance itself does not change. Prodrug has to change the substituent in a more demanding way called covalent bonds. The chemical structure is different from the original drug. In this regard, the Intellectual Property Trial and Appeal Board (first trial) interpreted prodrug as a new drug different from the original drug and sided with Dong-A ST. The pharmaceutical industry believes that if Dong-A ST wins the second trial following the first trial, the prodrug strategy will be a new breakthrough in overcoming material patents. It is predicted that another attempt will be made to overcome material patents through prodrucg development. Attention is also being paid to whether Dong-A ST will be able to release generic for Forxiga alone. Other generics in Korea can launch after April 2023, when the Forxiga material license ends. Dong-A ST has applied for permission for Forxiga's Prodrug last month. If Dong-A ST wins by the second trial following the first trial, it is predicted that it will enjoy the effect of preoccupying the market in for Forxiga's generic market. Dong-A ST has its own DPP-4 inhibitor-based diabetes treatment, Suganon and Sugamet. Securing SGLT-2-based drugs with Forxiga's Prodrug is expected to create considerable synergy in the diabetes treatment market. According to UBIST, a pharmaceutical market research firm, Suganon and Sugamet's outpatient prescriptions amounted to 32.6 billion won last year. Forxiga posted 42.6 billion won in prescription last year.
- Policy
- “Will provide systemic support for homegrown mRNA vaccines"
- by Lee, Hye-Kyung Feb 11, 2022 05:55am
- The Ministry of Food and Drug Safety promised to spare no effort in providing institutional support so that domestic companies can foster mRNA vaccine manufacturing and development capabilities. On the 9th, Food and Drug Safety Minister Gang-lip Kim held a roundtable meeting with vaccine R&D developers and experts that are participating in the ‘mRNA Bio-venture consortium’ at Quratis’ production facility (Osong, North Chungcheong Province) to discuss measures to support the development of homegrown mRNA vaccines. Members from the Vaccine Center for Assisting Safety & Technology, Korea biomedicine Industry Association, Eyegene, Geneone Life Science, Quratis, Boryung Biopharma participated in the meeting. mRNA(messenger RNA) platform has been receiving much attention as an innovative platform for pharmaceutical development, as the technology may significantly reduce the time and cost required for manufacturing pharmaceuticals and can be applied to treat various diseases including cancer in addition to vaccines. The roundtable meeting was prepared for the government to listen to the needs in the field and discuss measures for support, as the MFDS plans to actively support the system and infrastructure necessary for developing the mRNA platform technology in Korea. At the meeting, vaccine developers and experts agreed that although securing the source technology is important for developing homegrown vaccines using mRNA technology, fostering professionals and implementing advanced regulatory science are most important for the commercialization of the vaccines. In other words, the industry asked for the MFDS’ continued efforts in advancing relevant regulations and fostering related personnel for the development of the biopharmaceutical industry. Minister Kim said, “Development homegrown mRNA vaccines is a must not only to overcome the current COVID-19 pandemic but to prepare for new epidemics and ensure public safety. We will spare no effort in providing institutional support so that domestic companies can foster mRNA vaccine manufacturing as well as development capabilities. Kim added, “We are committed to improving public health and will continue to conduct approval reviews based on expertise and regulatory science while fostering experts in the area. I ask you for your best efforts in developing domestic vaccines to protect the health and safety of our people.”
- Policy
- It's hard to handle free national support for self-diagnosis
- by Lee, Jeong-Hwan Feb 11, 2022 05:55am
- Prime Minister Kim Bu-Gyeom expressed disapproval of the ruling party's proposed "free support for self-diagnosis kits for the whole country." This is because the production of diagnostic kits is currently insufficient to cover free distribution across the country. On the 8th, Prime Minister Kim responded to a question from Rep. Shin Hyun-young of Democratic party of Korea in a comprehensive policy inquiry by the National Assembly's Special Committee on Budget and Settlement. On the same day, Rep. Shin asked, "The ruling party has argued that free supply to the whole country is needed." In fact, when the National Assembly's Health and Welfare Committee decided on the supplementary budget review on the 7th, the unit opinion said, "The government is considering supplying self-inspection kits to the entire nation." Demand for self-diagnosis kits has increased significantly recently as the government has implemented a quarantine policy that allows PCR tests only when positive results are obtained in rapid antigen tests. Prime Minister Kim said, "The production itself is difficult to cover the nation's free distribution of self-kits," explaining, "We made about 200 million kits a year, of which 100 million kits have to be exported, so there is a limit to production to free support with the rest." Regarding criticism that the government should adjust its own kit consumer sales price to less than 2,000 to 3,000 won, Prime Minister Kim replied, "The distribution process will also cost appropriate supply," adding, "We will decide with the MFDS and organize it quickly so that there will be no confusion." Meanwhile, according to the government, the current public sector procurement unit price per kit is about 2,350 won, and the market price is between 7,000 won and 8,000 won.
- Opinion
- [Desk] 550,000 soldiers and COVID-19 vaccine
- by Nho, Byung Chul Feb 10, 2022 05:54am
- In mid-August last year, the Ministry of National Defense completed the first and second vaccinations against 550,000 soldiers. The types are identified as Moderna and Pfizer vaccines, including the Janssen vaccine. It deserves to be evaluated as a "successful vaccine operation" achieved quickly in a quasi-war situation facing North Korea. Currently, all COVID-19 prevention vaccines in circulation have an ERA of more than 70% based on the WHO. Therefore, the completion of vaccinations for all troops is essential for maintaining and improving combat power. What is particularly interesting is the joint civilian-military vaccination program. This refers to an operation jointly conducted by private consigned medical institutions and military hospitals from December 13 last year to January 14 this year. The intention of the operation, which was temporarily carried out, is to guarantee the right to self-determination and achieve a rapid vaccination rate for Armed Forces soldiers. Compared to the military's traditional closed organizational culture for security maintenance and military establishment, this operation is an unusual policy. Military hospitals mobilized at the time of the first and second inoculations are counted as 91 clinics, including Army, Navy, and Air Force medical units. The military hospital consists of 17 nursing institutions, including the Korean Armed Forces Capital Hospital. Affiliated institutions include the Armed Forces Medical School, the Armed Forces Medical Research Institute, and the General Medical Situation Center. At the time of the third inoculation, the number of privately entrusted medical institutions cannot be revealed as private. However, 10% of all soldiers, that is, about 55,000 out of 550,000 Armed Forces soldiers, were vaccinated at outpatient clinics, not military hospitals. The Ministry of National Defense collected soldiers who wanted to be vaccinated in private hospitals and received medical treatment by bus. The same per capita vaccination cost as the private sector of 19,000 won was applied. In other words, about 1 billion won in defense budget has been spent on private medical institutions. It is estimated that there are about 3,000 military doctors and nursing officers in Korea. They are considered experts who have completed their professional qualifications after graduating from medical school or have completed elite medical education at the Armed Forces Nursing School. Some point out that when inoculated at a military hospital, medical personnel could save taxpayers' money for aesthetic purposes. However, there is something that should not be overlooked here. It is commendable that their own military organization is interested in the needs of the people and the human rights of military soldiers, and is making a gesture of communication. It is also commendable that soldiers stopped by an outpatient pharmacy located near the hospital to purchase antipyretic analgesics such as acetaminophen and ibuprofen, and revitalized the surrounding commercial districts, although small. Parents with sons who joined the military are very worried about side effects after vaccination. In this situation, it can be seen as a reform through change that soldiers were allowed to decide to vaccinate. At a time when policies such as the volunteer military system and salary increase are being discussed, the time has come to discuss the reorganization of the public-private joint medical system related to the improvement of military medical rights.
- Company
- Skyrizi adds psoriatic arthritis indication
- by Feb 10, 2022 05:54am
- Pic of Skyrizi Abbvie’s ‘Skyrizi’ has expanded its indication to psoriatic arthritis. As the fourth interleukin inhibitor to receive approval for the indication, Skyrizi has set out to overtake the market with its convenience in administration. On the 9th, Abbvie Korea has held a ‘Press Conference to celebrate Skyrizi’s indication expansion to psoriatic arthritis’ online. Skyrizi, which was first approved for moderate-to-severe plaque psoriasis in 2019, added the psoriatic arthritis indication on the 5th of last month. Skyrizi may be used to treat adult patients with active psoriatic arthritis who had responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs). Professor Young-Beom Choi of the Department of Dermatology at Konkuk University Hospital said, “Biologic drugs tend to lose their effect with long-term administration due to tolerance issues and need to be replaced with other drugs. Therefore, we doctors are pleased that a new treatment option has been introduced to the area. Skyrizi has provided new treatment opportunities to patients with its improved convenience in administration.” Young-Beom Choi, Professor of Dermatology at Konkuk University Hospital Psoriatic arthritis, which is related to psoriasis, develops in various forms such as peripheral arthritis, dactylitis (inflammation of the fingers and toes), skin psoriasis, and enteritis. It affects all joints but is especially common in smaller joints such as the hands and feet. Around 10% to 15% of patients who develop psoriasis progress to psoriatic arthritis in 4 to 5 years. Skyrizi’s efficacy in psoriatic arthritis was demonstrated in the two Phase III KEEPsAKE-1and KEEPsAKE-2 trials. The drug showed a significant effect compared to placebo in the primary endpoint of ACR20 (20% improvement in joint symptoms) at week 24. In the two studies, 57% and 51% of patients receiving Skyrizi achieved the primary endpoint of ACR20 response at week 24, respectively, compared to the 34% and 27% receiving placebo. Also, the patients’ presence of enthesitis and dactylitis had improved by 24 weeks and the effect was maintained until week 52. Skyrizi was late to receive approval for the psoriatic arthritis indication than Tremfya, another drug that has the same mechanism of action. Tremfya received approval for the psoriatic arthritis indication in April last year and became the 3rd interleukin inhibitor to receive approval for the indication. Other interleukin inhibitors that had been previously used are the IL-17 inhibitor ‘Cosentyx’ and ‘Taltz.’ Late in entering the market, Skyrizi is attempting to expand its market share with its differentiated advantage, its less frequent administration regimen. Professor Choi also pointed to the dosing schedule as Skyrizi’s most prominent feature. Skyrizi is administered the least in a year among all IL-17 and IL-23 inhibitors. Contrary to IL-17 inhibitors that are administered every 4 weeks, 12 times a year, Skyrizi is administered every 12 weeks, 4 times a year. Professor Choi said, “Younger adults who work have difficulty visiting hospitals every month. Patients prefer Skyrizi because they only need to visit once every three months. In addition to comorbidities and symptoms, patient preference is also an important factor considered when selecting drugs.” In addition to psoriasis and psoriatic arthritis, Abbvie plans to expand the reach of Skyrizi further to various autoimmune diseases. Seok-Yui Kim, Director of Medical at AbbVie said, “Global Phase 3 trials for Skyrizi are ongoing in Crohn's disease, ulcerative colitis, and the rare autoimmune disease hidradenitis suppurativa.”
- Company
- SK Bioscience releases second batch of COVID-19 vaccines
- by Kim, Jin-Gu Feb 10, 2022 05:54am
- SK Bioscience announced that it had shipped its second batch of commercial COVID-19 vaccine products. By manufacturing vaccines for AstraZeneca and then Novavax, the industry's evaluation is that the company has well demonstrated its large-scale and stable manufacturing capacity. SK Bioscience announced that it had shipped the first batch of Nuvaxovid from its L House in Andong, North Gyeongsang Province in the morning of the 9th. The released batch is predicted to be 840,000 doses of the vaccine that was approved for lot release by the Ministry of Food and Drug Safety the day before. SK Bioscience plans to ship out 2 million doses by the end of this month. Also, the manufacturing amount is expected to further increase from next month. SK Bioscience had signed an agreement with the government to supply 40 million doses of Nuvaxovid within this year. This is twice the amount of AstraZeneca’s vaccines that were supplied by the company to Korea last year. Last year, AstraZeneca signed a CMO deal with SK Bioscience to supply 20 million doses of its vaccine. SK Bioscience is known to have supplied 9,998,300 doses of AstraZeneca’s vaccine just in August last year, demonstrating its ability to manufacture and supply up to 10 million doses a month. SK Bioscience is considered to have well demonstrated its large-scale vaccine production capacity with its verified commercial batches of AstraZeneca and Novavax vaccines. Biologic agents, including vaccines, require quality verification by the MFDS every time a batch is produced for commercialization. According to SK Bioscience, its L House can manufacture up to 560,000 doses of vaccines per day. Multiplying the capacity by 252 working days, the maximum manufacturing capacity of the plant can be estimated to be around 141.12 million doses. By Q3 of last year, SK Bioscience had manufactured 43.25 million doses of vaccines, including AstraZeneca’s vaccines. In only 3 quarters, the company had manufactured four times the 11.48 million doses it had manufactured during the previous year. By the end of last year, the company had manufactured over 60 million doses. Based on the company’s stable manufacturing capacity, SK Bioscience anticipates it will be able to produce its own COVID-19 vaccine ‘GBP510’ in development without any problem even if it is approved in the first half of this year Currently, 9 lines are in operation in the L House. Excluding the one line used to preserve vaccine solutions (cell bank), a total of 8 lines are being used for the actual manufacturing of vaccines. 3 of the lines produce finished Nuvaxovid vaccine products for domestic supply. 2 of the other 5 lines produce vaccine solutions for separate supply to Novavax. The remaining 3 lines produce chickenpox, shingles, and pneumococcal vaccines. If GBP510 is approved in the first half of the year and starts being supplied in earnest in Korea, the company may switch a few of the chickenpox, shingles, and pneumococcal vaccine manufacturing lines for its manufacture. SK Bioscience plans to further expand its production capacity in the long term. The company plans to expand its manufacturing facility in two phases. First, the company has secured a new site near L House to establish additional manufacturing facilities for finished products such as pre-filled syringes and liquid vials by 2024. Also, the company set a goal of adding 12 animal cell incubators of a 2,000-liter scale and two microbiological incubators of a 1,000-liter scale at the same time. As the second step, the company plans to additionally secure manufacturing facilities for raw and finished products to triple its capacity by 2026.
- Company
- Effect of the release of generics for Tamsulosin
- by Ji Yong Jun Feb 10, 2022 05:54am
- The size of the Tamsulosin market, a treatment for prostatic hypertrophy, has soared. The market is also expanding as the influence of generic products has increased since the patent expired in 2015. According to UBIST, a pharmaceutical market research firm, on the 5th, Tamsulosin's outpatient prescription amount last year was 191.2 billion won, an increase of 5% from the previous year. The Tomsrosine market, which was worth 136.9 billion won in 2017, grew 40% in four years. Tamsulosin is α blocker that selectively act on bladder and prostate receptors to lower side effects. It is an ingredient prescribed for prostate hypertrophy patients. As prostate hypertrophy is an senile disease, the number of patients is also increasing recently. According to The HIRA, the number of patients treated for prostate hypertrophy in 2020 was 1.34,329, an increase of 9.4% from 2017 (1191,1595). Tamsulosin is analyzed to have expanded the market in line with the increase in prostate hypertrophy patients and the generic offensive. After the expiration of the original Harunaldi's patent in 2015, generics began to enter the market one after another. As of last year, 87 companies are competing in the Tomsrosine market, as the number of companies entering the generic market has steadily increased. Generics are increasingly influential in the Tamsulosin market. Last year, the amount of outpatient prescriptions for Tomslosin was 116.7 billion won, up 14% from the previous year. Tomslosin, which was worth 63.7 billion won in 2017, increased 83% in four years to 116.7 billion won in 2021. Generic's market share also jumped 14.5% points from 46.5% to 61% during the same period. Among the generics, Hanmi Tams of Hanmi Pharmaceutical and Hanmi Tams OD stood out. The amount of joint prescriptions for the two items last year was 31.7 billion won, up 16.1% from the previous year. Compared to four years ago, it surged 174%. It increased 27.6% from 11.6 billion won in 2017 to 14.8 billion won in 2018, and continued to grow to 19.8 billion won in 2019 and 27.3 billion won in 2020. Industry people say that the introduction of higher capacity than the original was the main reason why Hanmi Tams and Hanmi Tams OD were able to grow. Among generics, Genuonescience's Taminal amounted to 7 billion won, up 3.9% from the previous year. In addition, Dongkoo's Uropa, Kyung Dong's Uronal, Daewoong Bio's Bearosin, and Celltrion 's Tamsol raised more than 4 billion won in outpatient prescriptions. Sales of the original Harnal-D of Astellas are slowing down a little due to the release of generics. Last year, sales of Harnal-D amounted to 74.5 billion won, down 6% from a year earlier. Compared to the amount of outpatient prescriptions in 2017, it increased by 2%. Harnal-D increased 10.8% over the past two years from 73.2 billion won in 2017 to 81.1 billion won in 2019. However, in 2020, the following year, it fell 1.9% from the previous year to 79.6 billion won, and the decline continued last year.
- Company
- Sales in the PPI market are↑ 60% over the past 3 years
- by Kim, Jin-Gu Feb 10, 2022 05:53am
- The PPI anti- ulcer drug market has changed rapidly since the Ranitidine crisis. The market expanded sharply shortly after Ranitidine crisis, but growth has slowed down in the past year. Esomeprazole, Rabeprazole, and Ilaprazole enjoyed the reflective effect of Ranitidine crisis. On the other hand, in the case of Lansoprazole and Pantoprazole, it was difficult to expand their influence on the Ranitidine situation. ◆PPI market grows 61% compared to just before Ranitidine crisis According to UBIST, a pharmaceutical market research firm on the 4th, the amount of outpatient prescriptions for PPI-based anti- ulcer drugs last year was 732.5 billion won. Compared to 454.9 billion won in 2018, it increased by 61% in three years. PPI-based anti- ulcer drugs are the treatments that treat peptic ulcers and gastroesophageal reflux diseases by blocking proton pumps, the final stage of gastric acid secretion, and maintaining a high hydrogen ion index (pH) in the stomach. The reason for the rapid expansion of the market is the Ranitidine incident that occurred in 2019. In June 2019, impurities were detected in Ranitidine, an H2 receptor antagonist-based anti- ulcer drug. Eventually, the sale of this drug was stopped. When Ranitidine, the most commonly used in the market, was removed from the market, and PPI-based drugs enjoyed reflective effects. The annual prescription performance of PPI drugs by year increased to around 10% every year until 2018. In 2019, when the Ranitidine crisis occurred, the increase increased by 18% year-on-year. Then, in 2020, when Ranitidine was completely removed from the market, it increased 24% year-on-year. However, the growth trend that has continued since Ranitidine crisis last year seems to have slowed somewhat. The prescription amount of PPI-based drugs increased by 10% to 732.5 billion won last year. Some analysts say that the rapid growth of K-cab, a new P-CAB anti- ulcer drug, and the prolonged COVID-19 crisis have played a combined role. HK inno.N's K-Cab has posted 30.9 billion won in prescription performance that year since its release in March 2019. In 2020, it more than doubled to 76.1 billion won. Last year, it recorded 109.6 billion won, exceeding 100 billion won in prescriptions in the third year of its launch. ◆Esomeprazole·Ilaprazole vs Lansoprazole·Pantoprazole Esomeprazole, Ilaprazole, and Rabeprazole greatly expanded their influence after Ranitidine crisis. The drug that enjoyed the greatest reflective effect is Esomeprazole. Esomeprazole posted 319.4 billion won in prescription last year. Compared to 19.8 billion won in 2018, before Ranitidine crisis, it increased 63%. In the case of Rabeprazole, it increased 34% from 125.9 billion won to 169.1 billion won during the same period. Ilaprazole increased 33% from 28.3 billion won to 37.6 billion won. In the case of Lansoprazole and Pantoprazole, it is analyzed that they did not enjoy the reflective effect properly despite the gap of Ranitidine. Lansoprazole's prescription amount increased only 4% from 49.1 billion won in 2018 to 51 billion won last year. Pantoprazole increased 4% from 34.7 billion won to 36.3 billion won during the same period. Last year, both ingredients showed a decrease in prescription performance compared to the previous year.
- Company
- Opdivo to be deliberated by CDDC for stomach cancer indicati
- by Eo, Yun-Ho Feb 09, 2022 06:10am
- Whether a reimbursed treatment option would become available in the field of gastric cancer is receiving attention. According to industry sources, Ono and BMS’s PD-1 inhibitor immuno-oncology drug ‘Opdivo (nivolumab)’ will be deliberated by the National Health Insurance Service’s Cancer Disease Deliberation Committee on the 23rd of this month. In June last year, the Ministry of Food and Drug Safety approved an additional indication for Opdivo as ‘first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction or esophageal adenocarcinoma.’ With the approval, Opdivo became the first and only immunotherapy to be approved in Korea as first-line treatment for gastric cancer. Gastric cancer is considered to be the most important area in need of extended reimbursement for immunotherapy drugs after lung cancer. Gastric cancer is the most prevalent cancer and the fourth most common cause of cancer deaths in Korea. Although gastric cancer has a favorable survival rate when detected in its early stages, its relative survival rate drops to 5.9% with distant metastasis. The current standard of care for HER2-negative gastric cancer has been chemotherapy for the past decade due to the unavailability of new drugs approved for its first-line treatment. Opdivo is expected to become a suitable alternative for these patients. Meanwhile, the efficacy of the combination therapy using Opdivo was demonstrated in the large-scale, Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive the Opdivo combination compared to the 11.6 months in the control group. Among PD-L1 positive patients (CPS ≥ 5), mOS of the group receiving the Opdivo combination was 14.4 months, a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group in both the all-randomized population and PD-L1 positive patients.
