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This nasal lorazepam formulation utilizes Elans proprietary NanoCrystalR Technology and is in development for the out-patient treatment of emergency seizures in epilepsy patients, specifically status epilepticus and acute repetitive seizures.
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Among the factors that could cause actual results to differ materially from those described or projected herein are the following, risks relating to the Companys ability to maintain its Nasdaq listing including the risk that the Company may not successfully appeal a Nasdaq delisting determination; Amarins ability to maintain sufficient cash and other liquid resources to meet its operating requirements; the success of Amarins research and development activities, including its planned clinical trials in cardiovascular disease and; decisions by regulatory authorities regarding whether and when to approve Amarins drug applications, as well as their decisions regarding labeling and other matters that could affect the commercial potential of Amarins products; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the success with which developed products may be commercialized; competitive developments affecting Amarins products under development; the effect of possible domestic and foreign legislation or regulatory action affecting, among other things, pharmaceutical pricing and reimbursement, including under Medicaid and Medicare in the United States, and involuntary approval of prescription medicines for over-the-counter use; Amarins ability to protect its patents and other intellectual property; claims and concerns that may arise regarding the safety or efficacy of Amarins product candidates; governmental laws and regulations affecting Amarins operations, including those affecting taxation; general changes in International and US generally accepted accounting principles; and growth in costs and expenses. On 4 th week, prolactin levels came to baseline 22,3 ng,ml; there was 40 percent improvement in BPRS total score; MADRS score was 9; ASEX score was 14; CGI-I score was 3; and CGI-efficacy index score was 6, indicating improvement.
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