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Opinion
[Reporter’s view] Yuhan's CEO Lee made a big decision
by
Lee, Seok-Jun
May 13, 2020 05:54am
Jung Hee Lee, Yuhan CEO, is due until March next year. This is due to the company's policy of having two consecutive terms in three years. It will end in March next year. since he started working in March 2015. Most CEOs make their performances within their tenure. This is because 'maximum performance since its founding' can be a 'decoration' for their career. However, CEO Jung Hee Lee does not care about performance. Last year's (0.84%) and the first quarter's (0.35%) operating margin were the lowest, but the technology fee, which is a positive factor in earnings, is divided as conservatively as possible. The recent business report confirms this trend. Yuhan extended the expiry date of LO’s upfront fee for three cases. This is different from the report of the third quarter of last year. LO’s upfront fee for Lazertinib (anti-cancer drugs) exported to Janssen ($30 million) has extended from 2020 to 2021. The upfront fee for non-alcoholic steatohepatitis treatment, (NASH) YH2574 ($38 million), licensed out to Beringer, was extended from 2020 to 2022. the upfront fee for NASH treatment, sold to Gilead was set to be until 2021. Previously, only the principle of split recognition was disclosed, and the end date was not disclosed. In short, Yuhan delayed the completion of unfront fee accounting until 2022. The intention is to secure a fixed profit by dividing the down payment by 2022. This is a big decision for CEO Lee. If all of the LO’s upfront fee were reflected within the term, better results were possible in terms of sales and operating profit. The LO’s upfront fee left by Lee can strengthen the next CEO. This is because fixed profits are the driving force for maintaining R&D continuity without compromising earnings. Yuhan has a tradition of competing for two vice presidents and choosing a president. Either Wook-je Jo, Vice President (Management Division) or Jong-hyun Park, Vice President (Pharmaceutical Business Division) is a strong candidate. For one of them, CEO Lee's management to prepare for the future can be a valuable asset.
Opinion
Time to stop the delay in drug patent conflict
by
May 08, 2020 06:33am
Professor Kim Kwan Shik The world bombarded with COVID-19 related news has been disheartening. Even the new coined term ‘Corona Blue’ was trending. But on the lighter side, I came across some good news for myself, who mainly lectures and researches on patent law depicted in news articles. It was from a global pharmaceutical company, AbbVie announcing it would give up on the global patent rights to Kaletra, a potential COVID-19 treatment. In other words, anyone can make a copycat version (generic) of Kaletra. Anyone with a slightest interest in the industry would understand that giving up on a patent right means a tremendous commitment. Considering pharmaceutical companies are spending astronomical expense to protect and extend the pharmaceutical patent right as much as possible, the news actually sounded a little ironic. Global and Korean pharmaceutical companies use various tactics to prolong the market exclusivity period protected by the patent rights. One of the most popular strategies is ‘patent term extension.’ A patent’s term is valid until 20 years after the patent issue date, but in some cases it could be extended up to five years. As for pharmaceutical patent, a drug with listed patent cannot be commercialized immediately as it has to receive marketing approval from Ministry of Food and Drug Safety (MFDS) reviewed based on efficacy and safety data collected from clinical trial. Taking account of the time spent on the administrative procedure, the term can be extended up to five years. Many of Korean pharmaceutical companies tend to manufacture generics that copy original products with expired patent and sell them in inexpensive pricing. And by doing so, conflicts arise frequently due to the possibility of infringing patent rights. A famous case reported recently was on a drug sharing same effect with a patented original drug, but was using an incrementally modified substance uniquely approved by MFDS. The conflict fired up as the original drug company claimed the modified drug maker has infringed its patent right with extended term. In the end, the pharmaceutical industry was disconcerted by a staggering decision of the Supreme Court overruling the lower-instance Court’s conclusion that the patent was not infringed. Another pharmaceutical company has requested negative confirmation of the original’s patent scope to the Intellectual Property Trial and Appeal Board claiming that an item sold with effect and benefit, initially not acknowledged for the original’s patent that based the term extension, is not infringing the extended patent right of the original. However, the legal conflict has been on hold due to the COVID-19 pandemic. The order of strict social distancing has slowed down the court proceedings. Probably the pharmaceutical company pursuing the Court’s decision would be deeply frustrated as it needs to complete all procedures before the product launch. Recently lost in a series of term-extension related patent trials, pharmaceutical companies should not be hindered by the ‘delay in proceedings,’ when they have finally found an alternative strategy. This specific case and its follow-up trials would play a crucial role in the Korean pharmaceutical industry, as it could harmoniously arbitrate the conflict among pharmaceutical sovereignty, financial health of National Health Insurance, patients and stakeholders of the Korean pharmaceutical industry. Sources say the damage taken by pharmaceutical company from the pandemic is resulting in stagnating economic growth. The patent law was found to protect and promote invention and to contribute in industry advancement. The Intellectual Property Trial and Appeal Board and the Court should promptly make a reasonable decision, in accordance with the original objective of the patent law, for the pharmaceutical companies continuing to take challenges amid the difficult times to propel the flourishing industry in Korea.
Opinion
[Reporter’s View] What COVID-19 revealed in drug industry
by
Kim, Jin-Gu
Apr 29, 2020 06:20am
The humanity will ultimately overcome the COVID-19 pandemic. But the problem is what follows next. Scholars around the world talk about the Post-COVID-19. Each of them theorizes their own seemingly realistic ideas of “New Normal.” Among all of their hypotheses, ‘giving science back to the public’ speaks to the heart. At an online forum convened on Apr. 28 regarding the Post-COVID-19 and the new normal, Professor Park Sangook of Earth and Environmental Sciences Department at Seoul National University stated, “The science and technology should find their way back to the public in the future.” In fact, it was on the 100th day since the first reported case of COVID-19 in Korea. His diagnosis was unyieldingly honest. He said the science and technology in pharmaceutical and bio sector have advanced remarkably, but they are skewed to specific areas. It is as it is. Quoting his words, regardless of developed countries, global pharmaceutical giants or Korean pharmaceutical and bio industry, no one can deny the fact their R&D was fixated on “profitable sector.” Every one of them was into developing chronic disease treatment and “happy drugs.” The result is what we see today. According to Professor Park Sangook, the humanity is “in a dire situation, where we helplessly face a simple virus generated from the nature.” In their defense, the companies could claim their concentration on profitable business is obviously justifiable with their corporate nature. However, considering the pharmaceutical and bio industry put down their roots in public healthcare, they need to take a look back at themselves even shunning the ‘bare minimum.’ The government’s role is essential in turning the corporations around. To let the companies open their eyes on the public healthcare, the government should pay more attention and provide further support. Motivated by the pandemic, the Korean government seems to be making various promises to provide support for the pharmaceutical companies responding against the threat of the infectious disease. The government means to properly compensate the companies developing treatment and vaccines for the virus. These should not be empty promises for temporary purposes. Not just to spike their stock prices, but the government should show pharmaceutical companies that taking up a challenge for the public interest, despite the risk in failure and loss, would be compensated appropriately. Only when the government takes the right action, science and technology would find their way back to the public.
Opinion
[Reporter’s view] Pharmacist's role to meet post COVID-19
by
Kim, Min-Gun
Apr 29, 2020 04:59am
COVID-19 is changing our lives and culture itself with more powerful infectious power than any other epidemic. Telecommuting and video conferencing, represented by social distance, began in earnest, and online shopping malls are booming. It is a daily routine of non-facing contact. Hong Nam-ki, Deputy Prime Minister and Minister of Economy and Finance also pointed to non-face-to-face meetings such as teleconference and video conferencing for economic policy since COVID-19 outbreak. In order to prevent the spread of infection in medical institutions, the government even allowed non-face-to-face treatment for people with chronic diseases and the elderly. The U.S. FDA also issued a deregulation guideline that lowered the barrier to entry into telemedicine during the COVID-19 epidemic in March. This is to activate telemedicine to prevent infection between face-to-face contacts. Non-face-to-face treatment is an issue directly related to the delivery of prescription medicines. The Korean Pharmaceutical Association is concerned about this. The government reassured that there was no expansion of telemedicine beyond the current law, saying that non-face-to-face care is needed to protect medical institutions and patients from COVID-19, a highly contagious infection. However, it is a sign that non-face-to-face counseling, such as telemedicine, will become necessary in the future in response to infectious diseases. However, the current social distance is accompanied by economic losses. There are also a lot of people who are tired of restraining outside activities. Accordingly, the government is considering the future health care system. There will be active discussions regarding non-face-to-face contact policies. The government is preparing to switch to a non-face-to-face, life-prevention system. It becomes social distance campaign in life. The most important countermeasures against the epidemic have been proved that quarantine measures through rapid inspection and confirmation, and that essential quarantine supplies should be supplied in a timely manner. This means that the diagnosis and prevention of infectious diseases is not the only role of medical institutions. Through the 5-day rotation mask distribution system, it was recognized that the pharmacy's role in the daily life prevention system is important. As the interest in the role of the pharmacist's skill that has been overlooked has been refocused, the pharmacist society should not be left behind by the post-COVID-19 era that will change in the future rather than clinging to telemedicine issues. The role of the pharmacist's function in the era of infectious diseases and the future are even more important. Masks, hand sanitizers, and disinfectants can also be bought at marts, but an expert who can explain the exact range of use and how to do it can be done by a pharmacist at the pharmacy. The role of the pharmacist in the daily life prevention system is inevitable. The pharmacist should conduct specialized training to cope with infectious diseases, and the trained pharmacist should be more professional in the prevention of life. In addition, specialized pharmacists in the prevention of infectious diseases should be fostered in accordance with the legislation of the specialized pharmacist system. If the pharmacist's skill is specialized, the opinion that pharmacists should be included in the health care providers will be more supported. In this case, expansion of the pharmacist's competency may also be considered. It can be considered that if the patient's care and prescription are stopped in response to an infectious disease that occurs simultaneously in a specific local medical institution, it is considered to be in accordance with the exhibition situation. If patient care and prescriptions are stopped in response to infectious diseases that occur simultaneously in certain local medical institutions, it will be like wartime situation. Before separation of prescribing and dispensing drugs, the pharmacy directly diagnosed the patient and took the role of prescribing and dispensing. In order to prevent the collapse of the health care system in the epidemic area, Measures for prescribing medicines temporarily by local pharmacies may be considered. Systematic protection measures should be prepared, such as storing personal protective equipment (PPE) for each pharmacist society and distributing it to member pharmacies when an epidemic occurs.
Opinion
[FOCUS]We expect the MFDS to act wisely on impurity measures
by
Chon, Seung-Hyun
Apr 22, 2020 06:02am
At the end of September last year, when the MFDS decided to stop selling all products of the anti-ulcer drug “Ranitidine,” the pharmaceutical industry reacted strongly. The MFDS decided to withdraw because Ranitidine has unstable properties and is always exposed to the risk of carcinogenic substance 'N-nitrosodimethylamine (NDMA)'. The pharmaceutical industry complained strongly about tough measures in Korea, saying that we have not yet concluded whether or not the drug is harmful, and it is reasonable for NDMA to recover only the products in question that have been overdetected. At the time, in the United States and the EU, only the manufacturing number of products exceeding NDMA was recovered. Nevertheless, the MFDS was confident of the measures, saying that it has tested NDMA the most in the world. The Food and Drug Administration (FDA) decided to withdraw the Ranitidine product in the market on the 1st, about six months after that. The FDA concluded that the market withdrawal was justified for the reason that the impurities contained in some Ranitidine formulations could be detected over time to be acceptable. This is what gave the MFDS the decision made six months ago. Although the US action cannot be a barometer for judging the right or wrong of our government's decision, as a result, the MFDS was acknowledged that it took six months ahead of the US to proactively take scientific action. It should be praised enough. The complaints that the MFDS' follow-up to Ranitidine was overly impatient remained too hasty. In recent years, the pharmaceutical industry is paying great attention to the follow-up of NDMA for the diabetes treatment drug “Metformin”. In December of last year, the Singapore Health Sciences Authority (HSA) retrieved three products for the reason that NDMA exceeding the daily allowance was detected as a result of investigating 46 items of Metformin preparations on the market. In Canada, Metformin preparations from three pharmaceutical companies have voluntarily recovered due to NDMA detection for a month since February. In the United States and the EU, there is still an ongoing defense against Metformin's NDMA risk. The U.S. Food and Drug Administration (FDA) released a survey of 10 Metformin products in circulation in the U.S. in February, suggesting that NDMA was detected in two products, but no recall was recommended. However, a US private research firm, Valisure, proposed to the FDA earlier last month, announcing an analysis that NDMA exceeding the daily allowance was detected in some products of the drug 'Metformin' in circulation in the U.S. for diabetes. The European Medicines Agency (EMA) released its findings in an official statement on the 3rd of last month as soon as possible, and announced that imformation investigation results for Metformin are imminent, saying that patients with type II diabetes should continue taking Metformin until further announcement. It has been around four months since the Metformin NDMA risk in Singapore has risen, but the MFDS has never released an official position. Last year, the MFDS announced the results of an interim check that NDMA was not detected in domestic distribution products within three days after receiving the information about the detection of residual NDMA in the United States. Compared to this, the Metformin case doesn't seem to be quick. The MFDS received data on the use of Metformin in December last year from pharmaceutical companies. Metformin's NDMA test method was also released on January 15th. Earlier this year, we conducted a collection test for Metformin drug substance, and recently visited pharmaceutical companies to collect finished medicines. This is the point that the announcement of the Metformin inspection is imminent. Of course, it is expected that the MFDS will have great concerns. Metformin is the first and most widely used drug for people with type II diabetes, so it is a burden to take drastic measures like Valsartan and Ranitidine. Any follow-up can lead to extreme confusion among medical staff and patients. However, follow-up measures that apply different standards for different drugs can reduce trust in the government. However, if the collection inspection is over, follow-up should not be delayed. We look forward to wise follow-up by the MFDS based on scientific evidence. Transparency in the policy-making process can be supported by the people.
Opinion
[Reporter’s eye] Measures about NDMA should be careful
by
Lee, Tak-Sun
Apr 16, 2020 06:34am
Measures are imminent when the MFDS begins testing by collecting finished products of Metformin, which are used as diabetes treatments. In last December, an excess of NDMA (N-nitrosodimethylamine), a carcinogen, was detected in Metformin preparations in Singapore. Since then, the MFDS has been conducting extensive investigations. After collecting and inspecting about 900 raw materials, it is believed that the investigation process is being expanded to the finished product and the process of selecting products with excess impurities is in progress. Although the results of the investigation are still unknown, some people have analyzed that NDMA was detected in the raw material and then expanded the investigation to finished products using the raw material. The MFDS only states that it is currently considering various aspects of the investigation direction and measures. Regardless of the results of the investigation, measures against Metformin preparations should be determined more carefully than existing NDMA-detected products. This is because Metformin is used as a primary treatment for type II diabetes treatments. Diabetes patients who are being treated for the first time are starting with Metformin. And. Metformin with other drugs, a combination of metformin and other ingredients is also on the market. There is also a survey that the size of the outpatient prescription market for drugs containing Metformin alone reaches ₩473.2 billion (Source: UBIST). Therefore, as in the case of Ranitidine, if Metformin is banned and recovered, there is no alternative drug, and the lack of alternative medications will create a great disruption for the market, medical staff and patients. Therefore, measures to minimize the impact should be prepared. The products of concern should be selected rather than a quick investigation. If there are medicines of concern for risk, the first priority is to protect the safety of the people through prompt action. The MFDS will have a lot of worries in many ways. There are conflicting results abroad. The U.S. FDA announced in mid-February that it did not recommend recovery because Metformin's NDMA issue was not serious, while some products are being recovered in Singapore and Canada. In the United States, a private research institute, Valisure, also suggested that FDA recover the product, saying that some Metformin products had excessive NDMA. It is best that NDMA does not exceed daily allowances in Metformin products, but if there are products detected in excess, measures should be taken to minimize the gaps in patient care.
Opinion
[Reporter’s View] Layoff isn’t always the key to COVID-19
by
Eo, Yun-Ho
Mar 30, 2020 06:19am
The pharmaceutical industry is suffering from an unprecedented scale of infectious disease outbreak with COVID-19. The executives are feeling restless from continuing to work from home and their stress of sales performance is deepening day by day. Amid worldwide pandemic, pharmaceutical companies are struggling to confirm transaction agreement or prescription statistics, and sales people unable to meet their accounts have substituted their everyday work with detailed simulation, academic education and other tests besides regular reporting. Many companies are recommending employees to take days off, but most of them have no intention to do so. When the government is urging for social distancing, taking a paid-leave is definitely a waste for anyone. Pharmaceutical companies’ influence on physicians’ prescription has been diminished as they are missing out on events to provide “financial profit” to the healthcare providers. Everyone is struggling, but salesperson became the number one candidate for layoffs, and even their financial support has shrunk. The managers are asking the employees to maintain their sales while reducing marketing budget. Korean companies, without early retirement plan (ERP) offered like multinational companies, are laying off employees ruthlessly, when the employees in Korean companies with less competitive products are barely keeping up with their sales. Of course, the ‘best sales person of the year’ are unaffected by the outbreak, but most of the sales people have been burdened with growing work-related stress for last few years. And the problem is the companies picking on them. Whenever they were faced with detrimental issues like dual penalty system, actual transaction price system, lump-sum drug pricing reduction and illegal rebate investigation, the companies pointed their fingers on their sales people. Some companies do not even properly compensate employees with severance pay when they are leaving companies out of stress from the pressure for performance. And other companies reassign underperforming sales people from private clinics to hospitals, or from hospitals to pharmacies. And soon after, they start quitting their jobs. Is it really because they were too weak to withstand the change? Surely, those issues did not occur because of the sales people who have been hectic amid the COVID-19 outbreak or the difficult sales environment. They are fully aware of the tricky situation. And downsizing would be inevitable in the hard times. But for the future, the executives and employees should sufficiently engage and interact with each other to contemplate on solutions together.
Opinion
[Reporter’s view] Social distance is urgently needed
by
Lee, Hye-Kyung
Mar 29, 2020 11:17pm
The government has nailed down the 15-day period from March 22 to April 5 as a decisive time to win the war against COVID-19. On the 21st, Prime Minister Sye-kyun Chung said, “We need a much stronger social distance” through the dialogue with the public. In fact, the government's policy is a bit late. The government emphasizes social distance, emphasized by attaching the adjective 'Much more powerful', but experts suggested social distance to prevent the spread of COVID-19 from early March. This is the Korean Medical Association's '3-1-1' campaign. The KMA proposed the first week of March as a week to get used to social distancing. According to the proposal, the government and local governments included employees who were not related to COVID-19 to consider temporary double shift jobs, but the campaign was useless. I wonder if it would have been like if the government had taken the opinions of experts at that time and set the current policy. The social distance campaign has made a detour. However, even if it is late, it is impossible to give up social distance. Beginning April 6th, elementary, middle and high schools will start. Universities that started classes with online lectures are also planning to conduct offline classes after April 6. As the movement that cannot be stopped by social distance begins, the next 15 days is a deadline that can prevent the spread of COVID-19 in the future. The government's strong recommendations will keep the people disciplined. The following are recommendations given to the national dialogue. Religious facilities, indoor sports facilities, and entertainment facilities are to be discontinued. If inevitable, it is necessary to observe the regulations for each type of facility and to refrain from using the multi-use facilities for 15 days. The refrain from using a multi-use facility means that you must refrain from going outside except purchasing daily necessities, and postpone or cancel private group meetings, appointments, and trips. “The 15 days” is an inflection point to prepare for a new life against COVID-19. In the meantime, with the timid excuse that there was no strong recommendation from the government, I hope that this will be different from this. On the day of the announcement of the prime minister's talk, I also canceled the appointments full on the cell phone scheduler with 'I'm sorry' one by one. The weekly Pilates was also postponed for two weeks. I hope that everyone will give up their selfish thoughts, and everyone will join the social distance campaign for the 15 days, win the war against COVID-19 and return to our daily lives.
Opinion
[Reporter’s view] Did they act honorably?
by
Kim, Jin-Gu
Mar 06, 2020 06:05am
Companies willing to develop COVID-19 treatment (or vaccines). Recently, press releases of this kind have increased in the reporter's mailbox. With the spread of the COVID-19 crisis, many pharmaceutical companies are jumping into the development of drugs or vaccines. But some do not seem pure intentions. It is obviously expected to float stocks. For example, Company A is developing a new drug that suppresses Cytokines, claiming it could be used to treat COVID-19. In addition, it added that it applied for an emergency clinical trial plan with the Ministry of Food and Drug Safety. Company B, which is developing a new antiviral drug, has announced that it has applied for approval for therapeutic use by the MFDS to administer a candidate substance that has not yet completed phase I clinical trials to COVID-19 confirmed patients. Company C that develops the TB vaccine is also working on developing a COVID-19 vaccine. The company will develop a universal COVID-19 vaccine that is not related to virus mutations with its immune booster technology. For other bioventures, the content of the press release is much the same. The three words are 'COVID-19', 'therapeutics' and 'development'. The rest is only convincing. Words such as 'IND' or 'NDA' are effectively not found anywhere else. It's hard to find out more about research and development. It does not explain how much work has been done on the treatment or vaccine and how effective the study has been. That's the reason for doubting the intention of some bioventures. There is no way to know if they have the capacity to develop COVID-19 medications or vaccines and how you are preparing for development. It's just a company's claim and a one-sided possibility. Most press releases are documented in a form close to 'copy & paste'. Posted on major Internet portals, the stock market reacts immediately. The media and the stock market have long established a symbiotic relationship. All three companies in the previous case have benefited significantly. Some stocks have hit the ceiling. I have a feeling of déjà vu. Let's go back to the 2015 MERS outbreak and as far back as the 2003 SARS outbreak. As it is, the corona virus was the cause. At that time, many companies announced that they would start developing drugs and vaccines. Of course, the stock price went up as a bonus. However, no one has ever succeeded in developing a cure or vaccine. I wonder how many companies that have declared their development have continued their research and development so far. Recently in China, a company called BrightGene Bio-Medical Technology lied about COVID-19 remedies and bought embarrassment. The company has said it has successfully mass-produced 'Remdesivir', which is expected to be a potential COVID-19 drug. Related stocks surged. It is said to have increased by nearly 60% over a month. The Shanghai SE came out. It was countered that it failed to obtain Remdesivir's manufacturing approval from Chinese pharmaceutical authorities. Not only did it lack qualifications, the Shanghai SE also made it clear that it was not capable of mass production. After all, BrightGene's share price plummeted 20% in one day. It is said that it has been steadily falling since then. Of course, I believe that not all pharmaceuticals that are involved in the development of COVID-19 medications have distributed the press release with a bad way as BrightGene. Certainly, there are companies that have been quietly working on COVID-19 treatments in difficult circumstances. Justice will assert itself. As time goes by and the COVID-19 outbreak is settled, Corporate conscience will be revealed. The headwinds at that time must be handled by the companies themselves. The media also needs to be self-reflection. Keep in mind that an uncritical paste article without fact check can be damaging to someone.
Opinion
[Reporter’s View] Irony in group-listing competing drugs
by
Eo, Yun-Ho
Mar 03, 2020 06:10am
Inducing competition between pharmaceutical companies could lessen the financial exhaustion, but National Health Insurance (NHI) reimbursement listing procedure would get delayed. Such is an irony we witness during high-cost new drug listing or reimbursement expansion procedures in Korea. The government could take an advantage of price competition between companies as drugs are expensive. Under the NHI system, savings could open up more opportunities. And more savings could affect coverage enhancement. But the issue is timing. It would be preferable to review reimbursement for all same-class drugs at once, but it is hardly feasible. Typically ranging from six months to over a year, the gap in timing of reimbursement listing application could be vastly dispersed. Regardless of the actual date of application submission and other delaying factors, the timing gap is crucial, because there are patients desperately waiting it. And the issue worsens usually with anticancer therapies. The government wishes to review drugs with significant financial impact all together, such as a CDK4/ 6 targeted therapy applying for reimbursement as a combination therapy with PD-1 or PD-L1 inhibiting immunotherapy Faslodex. It is obvious and somewhat understandable. A medication, a part of combination therapy, could fail to get listed for reimbursement and a pharmaceutical company could have been unenthusiastic about the government-proposed ‘trade-off (a policy to have the negotiating pharmaceutical company to lower pricing of off-patent drug and to compensate it with coverage on new drug).’ What has passed is past, and now is different. At least the tug of war between the government and companies should start properly. Whether it be Cancer Deliberation Committee or drug pricing negotiation, the government should be respectful and at least get ready to go. Pharmaceutical companies, who have applied first, are biting their nails as follow-on drugs competent to compete are emerging. COVID-19 is surely an urgent matter, but how could we let down cancer patients? Because there is no answer, a line should be drawn instead. We cannot wait for those sluggish drugs. Rather, the same-class group reimbursement listing review should rule out those latecomers.
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