or otherwise provide any competitive advantage, nor can we assure you that our licenses are or will remain in full force or effect, in which case we would similarly rely on trade secrets. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other advisers may unintentionally or willfully disclose our information to competitors. Enforcing a claim that a third-party entity illegally obtained and is using any of our trade secrets is expensive and time-consuming, and the outcome is unpredictable. In addition, courts outside the U.S. are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how. Notably, proprietary technology protected by a trade secret does not preempt the patent of independently developed equivalent technology, even if such equivalent technology is invented subsequent to the technology protected by a trade secret.
We are an "emerging growth company," as defined in the JOBS Act, and may remain an emerging growth company for up to five years following our initial public offering. For so long as we remain an
We completed our Phase 2 clinical program for zilucoplan in PNH patients in the second quarter of 2017 and announced top-line data in February 2018. During the second and third quarters of 2018, we held End-of-Phase 2 discussions with the FDA, the MHRA, and Health Canada. Based on FDA feedback, as well as advice provided by MHRA and Health Canada, we announced the design of a single-arm Phase 3 study in treatment-naïve PNH patients. In January 2019, we concluded scientific advice and protocol design discussions with the EMA. The EMA was not receptive to a single-arm study design to support approval of zilucoplan in PNH. We do not plan to alter the design of the Phase 3 PNH program, but are reassessing the likelihood of obtaining marketing authorization for PNH in the E.U.
Increasing expenditures for healthcare have been the subject of considerable public attention in the United States. Both private and government entities are seeking ways to reduce or contain healthcare costs. Numerous proposals that would effect changes in the U.S. healthcare system have been introduced or proposed in U.S. Congress, or Congress, and in some state legislatures, including reducing reimbursement for prescription products and reducing the levels at which consumers and healthcare providers are reimbursed for purchases of pharmaceutical products.
Wei, J. H. S. S. & Yu-ping, H. Y. D. J. Effect of Extracts from Olibanum and Myrrha and Their Compatibility on Platelet Aggregation and Antithrombin Activity. Chinese Journal of Experimental Traditional Medical Formulae. 17, 160–165 (2011).
Researchers from Eli Lilly have also achieved a continuous Grignard reaction using a continuous stirred tank reactor (CSTR) (8). The process was developed after mapping the operation space using knowledge about CSTR process parameters, the reaction kinetics, magnesium (Mg) sequestration efficiency, equipment characterization, and the impact of process disturbances on steady-state conditions. A reaction kinetics model was also developed, and computational fluid dynamics (CFD) models were applied to the equipment design. This approach enabled the development of a highly robust and safe commercial-scale process.
Bode-Böger, S. M., Scalera, F. & Ignarro, L. J. The L-arginine paradox: importance of the L-arginine/asymmetrical dimethylarginine ratio. Pharmacology & therapeutics 114, 295–306 (2007).
If developed and approved, we believe, due to its convenient product profile and our anticipated pricing flexibility, zilucoplan has the potential to transform the role of complement inhibition for the treatment of gMG and PNH and expand patient access. In developing its commercial presentation, we intend to leverage key properties of zilucoplan, including its stability at room temperature and small volume, as well as its low viscosity, resistance to shear forces, and compatibility with fine-gauge needles.
Anyway the point is, small efforts will add up, and decades more of healthy life are probably not all that far away.
Other than as described in “Item 5. Operating and Financial Review and Prospects—Contractual Obligations”, we have not had any material commitments for capital expenditures, including any anticipated material acquisition of plant and equipment or interests in other companies, since January 1, 2014. Additionally, we have not had any material capital divestitures since January 1, 2014.
Yang, J. et al. Smad-dependent and smad-independent induction of id1 by prostacyclin analogues inhibits proliferation of pulmonary artery smooth muscle cells in vitro and in vivo. Circ. Res. 107, 252–262 (2010).
To date, our independent public accountant has never conducted a review of our internal control for the purpose of providing the reports required by these rules. During the course of our review and testing, we may identify deficiencies and be unable to remediate them before we must provide the required reports. Furthermore, if we have a material weakness in our internal controls over financial reporting, we may not detect errors on a timely basis and our financial statements may be materially misstated. We or our independent registered public accounting firm may not be able to conclude on an ongoing basis that we have effective internal control over financial reporting, which could harm our operating results, cause investors to lose confidence in our reported financial information and cause the trading price of our stock to fall.
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