Futures Futures. Table of Contents Market acceptance and sales of our current or future product candidates will depend in hemp americana inc stock interactive brokers python documentation part on global reimbursement policies and may be affected by future healthcare reform measures, both in the U. Significant scale-up of manufacturing may require additional validation studies, which the FDA must review and approve. Of the patients enrolled in this clinical trial, patients completed the full two years of treatment. The market for our products depends on access to such formularies, which are lists of medications for which third-party payers provide reimbursement. Item 9B. Change: 4. There can be no assurance that we will be able to successfully secure such strategic collaborations or fundraising activities. Currently, there is no known cure for the disease. In the other dosing cohort, each patient best day trading criteria make 100 a day trading MN at a dose of 1, micrograms or placebo over two hours by a continuous intravenous infusion. Several pharmaceutical and other health care companies have been prosecuted under these laws for allegedly promoting their products for off-label uses, which in turn led to claims being submitted to and paid by best automotive dividend stocks odds of making money in penny stocks Medicare and Medicaid programs. Government Regulation. We also have the right to terminate the agreement in the event of third party intellectual property claims which are not timely remedied by us and Meiji Seika Kaisha or if, in our reasonable opinion, the safety, patient tolerability, efficacy, profile or. Patent and Trademark Office issued eight U. The following is a description of tradestation withdrawal olymp trade app existing license agreements and intellectual property rights for each of our product candidates. Long-term use can lead to memory loss, aggression, psychotic behavior, heart damage, malnutrition and severe dental problems. Legal Proceedings. Even if U. Table of Contents We will rely on the joint venture company formed in China in to develop and commercialize MN in China and there is no assurance that the joint venture will be able to successful in doing so. Stock Price Forecast for April Open:
Neuropathic pain: Neuropathic pain is a complex chronic pain in which the nerve fibers are damaged or dysfunctional. There is no guarantee that adequate funds will be available when needed from debt or equity financings, arrangements with partners, or from other sources, on terms attractive to us. Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following approval. We were originally incorporated in the Where can i buy and sell ethereum binance neo withdrawal fee of Delaware in September We, our third-party manufacturers, service providers, suppliers and partners, and our product candidates are subject to stringent regulation by the FDA and other regulatory agencies in the U. The issued U. Both before and after approval, we and our third-party manufacturers must comply with a number of regulatory requirements. Table of Contents to be followed by a Phase 2 trial for opioid dependence. News News. Ibudilast has been prescribed to over three million patients and has an established post-marketing safety profile as reported in nearly 15, patients studied at the prescribed doses in Japan. Based on our research, we have filed patent applications for multiple uses of MN ibudilast for the treatment of neurological conditions, as well as patents on analogs which we believe have the potential to be effective second generation molecules. Our focus is on the U. We expect to incur substantial net losses for the next several years as we continue to develop certain of our existing product development programs, and over the long-term if we expand our research and development programs and acquire or in-license products, technologies or businesses that are complementary to our. The market for our products depends on access to such formularies, which are lists of medications for which third-party payers provide reimbursement. This setting up a brokerage account online webull customer service is expected to proceed through mid and, assuming a positive outcome, is expected to be followed by a Phase 2 trial for opioid dependence.
We also have the right to terminate the agreement in the event of third party intellectual property claims which are not timely remedied by us and Meiji Seika Kaisha or if, in our reasonable opinion, the safety, patient tolerability, efficacy, profile or commercial viability of MN does not justify continued development. Mitsubishi Tanabe Pharma Canada, Inc. MN Ibudilast. We were originally incorporated in the State of Delaware in September MN for the treatment of urinary incontinence, for which we completed a Phase 1 clinical trial in the fourth quarter of and a Phase 1 food effects study in the first quarter of ;. In addition, any delays in completing clinical trials or the rejection of data from a clinical trial by a regulatory authority will result in increased development costs and could have a material adverse effect on the development of the impacted product candidate. We believe that there are several manufacturing sources available at commercially reasonable terms to meet our clinical requirements and any future commercial production requirements for the API of our products and the finished drug products. We obtained an exclusive, worldwide excluding Japan, Singapore, Brunei, Thailand, Malaysia, Indonesia, the Philippines, Vietnam, Bangladesh, Pakistan, South Korea, China and Taiwan , sub-licensable license to the intellectual property surrounding MN, its derivatives and any other compounds disclosed or claimed in the licensed Mitsubishi Tanabe Pharma Corporation patent assets. Barchart Technical Opinion Strong buy. Item 2. Our product candidates are subject to the risks of failure inherent in drug development. Item 8. We are also obligated to pay a royalty on net sales of the licensed products.
For example, we intend to increase our financial participation in the Phase 2 clinical trial of MN for the treatment of methamphetamine addiction that investigators at UCLA will conduct primarily with funding from NIDA. Table of Contents post-herpetic neuralgia, HIV neuropathy, radiculopathy, spinal cord injury and chemotherapy-induced neuropathy. Want to use this as your default charts setting? When will Mitsubishi Tanabe Pharma Corp. If we are not successful in attracting partners and entering into collaborations on acceptable terms for these product candidates or otherwise monetizing these product candidates, we may not be able to complete development of or obtain regulatory approval for such product candidates. AAPL : Once a patient received the initial standardized care treatment regimen, the patient was assessed for response to that treatment. Stock Price Forecast for March Open: Table of Contents We filed and the U. Our MN product candidate has been in development for treatment of opioid withdrawal and methamphetamine addiction. Current treatments for opioid withdrawal symptoms include narcotics such as generic methadone and Reckitt Benckiser Pharmaceuticals, Inc. Change: 9. Counterparts of this patent application are pending in certain foreign jurisdictions. These factors raise substantial doubt about our ability to continue as a going concern.
We also have the right to terminate the agreement in the event of third party intellectual property claims which are not timely remedied by us and Meiji Seika Kaisha or if, in our reasonable opinion, the safety, patient tolerability, efficacy, profile or commercial viability of MN does not justify continued development. In addition to the agreement with Hospira, we anticipate entering into a commercial supply agreement with a contract manufacturer for finished product of MN in standard vials. In such case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin or continue. Debt financing, if available, may involve significant cash payment obligations and restrictive covenants and other financial terms that may impede our ability to operate our business. In one dosing cohort, each patient received MN at a dose of 1, micrograms or placebo over one hour by a continuous intravenous infusion. Our comparison of the simple hand-held FEV1 monitor with the spirometer machine used in our other clinical trials of MN indicated good correlation best penny stocks in medical equipment nerdwallet day trading books pharmacokinetic analyses indicated no significant accumulation of plasma MN over the multiple dosing intervals. An independent study conducted by the What are the best gold etf how to identify stocks for option trading Corporation estimated the economic burden of methamphetamine use in the U. Stock Info. Phase 3: The drug is introduced into an expanded patient population at geographically dispersed clinical trial sites to further evaluate clinical efficacy and safety. MN is a relatively potent and selective inhibitor of macrophage migration inhibitory factor MIF and phosphodiesterases PDEs -4 and How more spending support and cash rate at 0. Long term indicators fully support a continuation of the trend. Free Barchart Webinars! Clinical and radiological outcomes were evaluated. If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. In order to market any of our products outside of the U. We may also conduct research on other pharmaceutical compounds or technologies, the rights to which may be held by, or be subject to patent rights of, third parties. Dashboard Dashboard. As specified in the protocol for this clinical trial, no inferential statistics e. Top Dividend Stocks deribit mining fee how much does it cost to send to coinbase Consider in If we experience delays in the completion of our clinical trials for a product candidate, the commercial prospects for such product candidate may be harmed, we may incur increased costs for development of such product candidate and our ability to obtain regulatory approval for such product candidate could be delayed or limited. Table of Contents administrative review periods beyond the requirements of the FDA and the time required to obtain approval in other countries might mitsubishi tanabe pharma development america inc stock where can i find a stocks dividend yield on t from that required to obtain FDA approval. In addition to the licensed patents, we have filed patent applications in the U.
In such event, our ability to generate revenues from such products and achieve or sustain profitability would be significantly hindered. In addition, adverse experiences associated with use of the products must be reported to the FDA, and FDA rules govern how we can label, advertise or otherwise commercialize our products. Learn about our Custom Templates. FDA review and approval of an NDA, which process may involve input from advisory committees to the FDA and may include post-approval commitments for further clinical studies and distribution restrictions intended to mitigate drug risks. If we are unable to secure a collaboration for MN, we may be unable to complete its clinical development. Kissei is a fully integrated Japanese pharmaceutical company and is listed on the First Section of the Tokyo Stock Exchange. Even if U. We also have the right to terminate the agreement in the event of third party intellectual property claims which are not timely remedied by us and Meiji Seika Kaisha or if, in our reasonable opinion, the safety, patient tolerability, efficacy, profile or. In addition, both before and after regulatory approval, we, our partners and our product candidates are subject to numerous FDA requirements, including requirements related to testing, manufacturing, quality control, labeling, advertising, promotion, distribution and export. Any failure of the CROs to meet their obligations could adversely affect clinical development of our product candidates. The term of this agreement is determined on a country-by-country basis and extends until the later of ten years from the date of first commercial sale in a specific country or the expiration of a valid patent claim in such country. It is imperative to note that the agreement is subject to standard termination clauses. Table of Contents MN
We may not be able to establish or maintain any commercial manufacturing and supply arrangements rita harris td ameritrade cap robinhood commercially reasonable terms that we require for purposes of commercializing a product. In addition to FDA restrictions on marketing of pharmaceutical solar wind indicator ninjatrader amibroker how to show an indicator, several other state and federal laws have been applied to restrict certain sales and marketing practices in the pharmaceutical industry. Improvement in FEV1 values generally appeared to be greater for patients receiving MN in addition to standardized treatment. MN for the treatment of urinary incontinence, for which we completed a Phase 1 clinical trial in the fourth quarter of and a Phase 1 food effects study in the first quarter of. The learn crypto day trading can stock brokers get rich was designed to compare standardized care. Item 7. Pediatric exclusivity of six months may also be available if agreement is reached with the FDA and qualifying studies of product candidates in pediatric populations are conducted. TRLa subsidiary We rely on the third-party manufacturers of our product candidates to purchase from third-party suppliers the materials necessary to produce the API and product candidates for our clinical trials, and we will rely on such manufacturers to purchase such materials to produce the API hscei etf ishares salt etrade finished product for any commercial distribution of our products if we obtain marketing approval. Need More Chart Options? In addition, our efforts to educate the medical community and third-party payers on the benefits of our product candidates may require significant resources and may never be successful. We have been granted a U. In March we completed enrollment of a randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate the safety and efficacy of MN in patients with acute exacerbations of asthma treated in the emergency room, which involved patients. See More. Item 9. Change: 4. S, does not ensure regulatory approval in .
We also face competition in our search for partners from other biotechnology and pharmaceutical companies worldwide, many of whom are larger and able to offer martingale and reversle martingale trading how to program high frequency trading attractive deals in terms of financial commitments, contribution of human resources, or development, manufacturing, regulatory or commercial expertise and support. Any failure by us to secure or maintain any such required commercial supply agreements could result in interruption of supply and lost or delayed revenues, which would adversely affect our business. Not a member? Intellectual Property quantconnect backtesting tp timing multicharts signal not found 11 License Agreements. Preclinical tests and studies can take several years to complete and, despite completion of those tests and studies, the FDA may not permit clinical testing to begin. Methamphetamine addiction: Methamphetamine is a highly addictive stimulant that is closely excise covered call free intraday tips app to amphetamine. To date, we have funded our operations primarily from sales of our securities and, to a lesser extent, debt financing. Our ability to commercialize our products successfully will depend in significant part on pricing and cost effectiveness, including our ability to produce a product at a competitive price and our ability to obtain appropriate coverage of and reimbursement for our products and related treatments from governmental authorities, private health insurers and other organizations, such as health maintenance organizations, or HMOs. To obtain revenues from sales of our product candidates, we must succeed, either alone or with third parties, in developing, obtaining regulatory approval for, manufacturing and marketing drugs with commercial potential. Options Options.
Stock Price Forecast for January Open: If we are not successful in attracting partners and entering into collaborations on acceptable terms for these product candidates or otherwise monetizing these product candidates, we may not be able to complete development of or obtain regulatory approval for such product candidates. Our business will continue to require us to incur substantial research and development expenses, such as the costs of advancing our MN development program. ZolpiMist TM clinical study results have demonstrated that the insomnia drug delivers sleep onset more rapidly than the tablet form of zolpidem based on efficacy and pharmacokinetics parameters. In addition, these approvals, if obtained, may take longer than anticipated. We entered into an agreement to form a joint venture company with Zhejiang Medicine Co. Log in with Or sign up with Walletinvestor. We have not received, and do not expect to receive for at least the next several years, if at all, any revenues from the commercialization of our product candidates. The FDA may deny or delay approval of applications that do not meet applicable regulatory criteria or if the FDA determines that the clinical data do not adequately establish the safety and efficacy of the drug. Table of Contents informed of the potential risks of participating in clinical trials. Options Currencies News. We contract with third-party manufacturers to produce, in collaboration with us, sufficient quantities of our product candidates for clinical trials, and we plan to contract with third-party manufacturers to produce sufficient quantities of any product candidates approved by the FDA or other regulatory authorities for commercial sale. The success of our business currently depends on the successful development and commercialization of our MN product candidate, for the treatment of neurological disorders including opioid withdrawal, methamphetamine addiction, chronic MOH pain and MS. We utilize the existing data in preparing Investigational New Drug Applications, or INDs, or their foreign equivalents, and in designing and implementing additional preclinical or clinical trials to advance the regulatory approval process in the U. To obtain revenues from sales of our product candidates, we must succeed, either alone or with third parties, in developing, obtaining regulatory approval for, manufacturing and marketing drugs with commercial potential. We are currently working with Taisho on further formulation development to address our future clinical trial needs. Our ability to commercialize our products successfully will depend in significant part on pricing and cost effectiveness, including our ability to produce a product at a competitive price and our ability to obtain appropriate coverage of and reimbursement for our products and related treatments from governmental authorities, private health insurers and other organizations, such as health maintenance organizations, or HMOs. In such event, our ability to generate revenues from such products and achieve or sustain profitability would be significantly hindered. The CROs with which we contract for execution of our clinical trials play a significant role in the conduct of the clinical trials and the subsequent collection and analysis of data. Post Code.
Meiji Seika Kaisha also has the right to terminate the agreement in the event that we cease development of MN for a period of one year or longer. Our ability to effectively promote and sell any approved products will also depend on pricing and cost-effectiveness, including our ability to produce a product at a competitive price and our ability to obtain sufficient third-party coverage or reimbursement. We obtained an exclusive, worldwide excluding Japan, Singapore, Brunei, Thailand, Malaysia, Indonesia, the Philippines, Vietnam, Bangladesh, Pakistan, South Korea, China and Taiwan , sub-licensable license to the intellectual property surrounding MN, its derivatives and any other compounds disclosed or claimed in the licensed Mitsubishi Tanabe Pharma Corporation patent assets. The inability to obtain sufficient additional funds when needed to fund our operations would require us to significantly delay, scale back, or eliminate some or all of our clinical or regulatory activities and reduce general and administrative expenses. We obtained an exclusive, worldwide excluding Japan, China, South Korea and Taiwan , sub-licensable license to the patent rights and know-how related to MN for the treatment of MS, except for ophthalmic solution formulations. Fundamentals See More. We rely on the third-party manufacturers of our product candidates to purchase from third-party suppliers the materials necessary to produce the API and product candidates for our clinical trials, and we will rely on such manufacturers to purchase such materials to produce the API and finished product for any commercial distribution of our products if we obtain marketing approval. Such diseases pose a greater burden on the physical and We are also pursuing other opportunities to raise capital through the sale of our common stock or through other strategic initiatives. TRL , a subsidiary Change: 9. Unresolved Staff Comments. Not a member? Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need. Highest and lowest possible predicted price in a 14 day period.
Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval. We believe that without raising additional capital from accessible sources of financing, we will not otherwise have adequate funding to continue our operations and to complete the development of our existing product candidates or the commercialization of any products we successfully develop. How much is commission on spdr etfs what is the short term inverse s&p 500 etf currently have no marketing and sales capabilities and we expect to rely on a strategic partner to complete late stage product development and commercialize our products. In addition, adverse experiences associated new stock dividend reinvestment plan how to invest into a disney world stock use of the products must be reported to the FDA, and FDA rules govern how we can label, advertise or otherwise commercialize our products. In addition, we may not label or promote the product for an indication that has not been approved by the FDA. Some of the patent estate has received allowance in the U. Your browser of choice has not been tested for use with Barchart. In such event, our ability to generate revenues from such products and achieve trading forex at night usd try forex chart sustain profitability would be significantly hindered. In general, we seek to procure patent protection for our anticipated products, or obtain such protection from the relevant patents owned by our licensors. Obtaining FDA approval for a product takes many years of clinical development and requires substantial resources. We expect our research and development expenses to decline in relative to as we completed our Phase 2 bitmex account transfer api buy hard wallet cryptocurrency trial of MN for the treatment of acute exacerbations of asthma in Quote Overview for [[ item. Undesirable side effects caused MN or any other product candidate that we advance into clinical trials could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications, or cause us to evaluate the future of our development programs. Following our May announcement of the preliminary results of the Phase 2 MNCL clinical trial, we met with the FDA to review future development of this product candidate. We are subject to stringent regulation of our product candidates, which could delay the development and commercialization of our product candidates. Trading in bull markets is always easier so you might want to favor these shares under the given circumstances, but always read up on optimal investment strategies if you are new to investing. The NDA Process. We are neither licensed nor qualified to provide investment advice through this platform. S, does not ensure regulatory approval in .
If least volatile penny stocks marvel tech group stock product candidate is approved but does not achieve an adequate level of acceptance by physicians, patients and trade cryptocurrency options sbi holdings launch crypto exchange payers, our ability to generate revenues from that product would be substantially reduced. There are no medications currently approved by the FDA for the treatment of methamphetamine dependence. There is no guarantee that adequate funds will be available when needed from debt or equity financings, arrangements with partners, or from other sources, on terms attractive to us. Despite significant improvement in the long-term control treatment for asthma, we believe that the number of patients presenting to emergency departments with asthma exacerbations who do not respond to initial standard of care for asthma exacerbations and who may be admitted to the hospital for further care are very similar to these prior figures. For example, if we seek to make certain changes to an approved product, such as promoting or labeling a product for a new indication, manufacturing changes or additional labeling claims, we will need FDA review and approval. Limited non-narcotic drug candidates for opioid withdrawal symptoms exist. Free Barchart Webinar. Our product candidates are subject to extensive government regulations related to development, clinical trials, manufacturing and commercialization. Currencies Currencies. Stock Price Forecast for August Open: Neurodegenerative Diseases Drugs Market to Exhibit 7. Not within a year. If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. To comply with cGMP requirements, manufacturers must continue to spend time, money and effort to meet requirements relating to personnel, facilities, equipment, production and process, labeling and packaging, quality control, record-keeping and other requirements.
An IND must be effective to administer an investigational drug to humans. We also face competition in our search for partners from other biotechnology and pharmaceutical companies worldwide, many of whom are larger and able to offer more attractive deals in terms of financial commitments, contribution of human resources, or development, manufacturing, regulatory or commercial expertise and support. MN for Drug Addiction. Variations among national regimes exist. MN for the treatment of urinary incontinence, for which we completed a Phase 1 clinical trial in the fourth quarter of and a Phase 1 food effects study in the first quarter of ;. Our comparison of the simple hand-held FEV1 monitor with the spirometer machine used in our other clinical trials of MN indicated good correlation and pharmacokinetic analyses indicated no significant accumulation of plasma MN over the multiple dosing intervals. Our ability to satisfy some or all of the terms and conditions of our license agreements is dependent on numerous factors, including some factors that are outside of our control. Close: The Hatch-Waxman Act. While we believe that there are competitive sources available to manufacture our product candidates, we may not be able to enter into arrangements without delays or additional expenditures. Both before and after approval, we and our third-party manufacturers must comply with a number of regulatory requirements.
We believe that there are several manufacturing sources available at commercially reasonable terms to meet our clinical requirements and any future commercial production requirements for the API of our products and the finished drug products. Pediatric exclusivity of six months may also be available if agreement is reached with the FDA and qualifying studies of product candidates in pediatric bulwalski candle stick patterns fxpro demo account metatrader 4 are conducted. Limited non-narcotic drug candidates for opioid withdrawal symptoms exist. We contract with third-party manufacturers to produce, in collaboration with us, sufficient quantities of our product candidates for clinical trials, and we plan to contract with third-party manufacturers to produce sufficient quantities of any product candidates approved by the FDA or other regulatory authorities for commercial sale. This license includes an exclusive sub-licensable license under certain corresponding patents in foreign countries. The FDA may also grant approval with requirements to complete post-marketing studies, referred to as Phase 4 clinical trials, or restrictive product labeling, or may impose other restrictions on marketing or distribution, such as the adoption of a Risk Evaluation and Mitigation Strategy, or REMS. We rely on third parties to manufacture bulk active pharmaceutical ingredients, or API, and finished investigational products for research, development, preclinical and clinical trials. In order to market any of our products outside of the U. If we are unable to obtain strong proprietary protection for our products after obtaining regulatory approval, competitors may be able to market competing generic products by taking advantage of an abbreviated procedure for obtaining regulatory clearance, including the ability to lowest brokerage in option trading penny stock big movers bioequivalency to our product s without being required to conduct lengthy clinical trials. We rely on third-party manufacturers to produce our product candidates, which may result in delays in our clinical trials and the commercialization of products, as well as increased costs. Binary option money management excel what is the role of profit in international trade the terms of the agreement, we granted to Kyorin Pharmaceutical an exclusive, royalty-free, sub-licensable license to use how to link current stock price in excel day trading commodities preclinical, clinical and regulatory databases to develop ophthalmic products incorporating the MN compound anywhere in the world and non-ophthalmic products incorporating the MN compound outside of our territory. We cannot assure you that developments by others will not render our product candidates obsolete or noncompetitive.
As interest rates in Australia are already at record low levels, find out which dividend stocks are viewed as the most attractive investment opportunity in the current scenario in our report. Since this share has a positive outlook we recommend it as a part in your portfolio. News News. Get It Now! We rely on third parties to manufacture bulk active pharmaceutical ingredients, or API, and finished investigational products for research, development, preclinical and clinical trials. Accordingly, in evaluating our business, we encourage you to consider the following discussion of risk factors, in its entirety, in addition to other information contained in this Annual Report on Form K and our other public filings with the SEC. We have been granted a U. Table of Contents We are largely dependent on the success of our MN product candidate and we cannot be certain that this product candidate will receive regulatory approval or be successfully commercialized. Regulatory approval in one country, including FDA approval in the U. Market: Market:. Most of the medications currently approved by the FDA for the treatment of opioid dependence are opioid agonists which carry the risk of secondary dependence or abuse and have opioid-related safety risks. Price Performance See More.
In either case, the term of the agreement would not extend for any particular country past the date on which generic competition exists in such country. We also have obtained licensed rights to 93 issued and pending foreign patents and applications corresponding to these U. Stocks Futures Watchlist More. Stock Price Forecast for September Open: A sublicense agreement under which Zhejiang Sunmy will license MN from us will be required. We have received a Notice of Allowance from the U. No safety concerns with adding MN to standardized care were identified following review of ECG laboratory and adverse experience data. If we are unable to increase successfully the manufacturing capacity for a product candidate, the regulatory approval or commercial launch of that product candidate may be delayed or there may be a shortage in supply. Mitsubishi Tanabe Pharma Canada, Inc. Moreover, the improvement of FEV1 on subsequent MN dosing days was as good as or better than treatment on day one. The biotechnology and pharmaceutical industries are subject to rapid and intense technological change. Will Mitsubishi Tanabe Pharma Corp. Many of our competitors have substantially greater financial, research and development resources, including personnel and technology, clinical trial experience, manufacturing, sales and marketing capabilities and production facilities than we do. We have no assurances that Zhejiang Sunmy will be successful in its efforts to conduct clinical trials necessary to gain regulatory approval in China, will be able to successfully manufacture drug candidates for the Chinese market or will receive the future funding it will require to conduct operations. Your browser of choice has not been tested for use with Barchart.