Sentences with phrase «making timely submissions»

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These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Timely Delivery: We understand the value of timely submission and make sure that the document reaches to you within the prescribed time without any Timely Delivery: We understand the value of timely submission and make sure that the document reaches to you within the prescribed time without any timely submission and make sure that the document reaches to you within the prescribed time without any delay.

KEY SKILLS • Demonstrated ability to carry out degree audit independently • Knowhow of all paper work required for document's submission at graduate and post graduate level • Able to communicate effectively and attract resourceful persons from the community to sponsor student activities • Experienced in arranging student community joint ventures for promotion of the university • Adept at keeping track of changed schedules and making sure the students are timely updated