Although we cannot predict the full effect on our business of the implementation of existing legislation or the enactment of additional legislation pursuant to healthcare and other legislative reform, we believe that legislation or regulations that would reduce reimbursement for, or restrict coverage of, Aramchol or any future product candidates, could adversely affect how much or under what circumstances healthcare providers will prescribe or administer our products. This could materially and adversely affect our business by reducing our ability to generate revenue, raise capital, obtain additional collaborators and market Aramchol or any future product candidates. In addition, we believe the increasing emphasis on managed care in the United States has and will continue to put pressure on the price and usage of pharmaceutical products, which may adversely impact any future product sales.

The market price of our ordinary shares is volatile and you may sustain a complete loss of your investment.

Meng, X. M., Chung, A. C. & Lan, H. Y. Role of the TGF-beta/BMP-7/Smad pathways in renal diseases. Clinical science. 124, 243–254 (2013).

Jin, R. C. & Loscalzo, J. Vascular Nitric Oxide: Formation and Function. J Blood Med. 2010, 147–162 (2010).

        If a product with orphan status receives the first FDA approval for the disease or condition for which it has such designation or for a select indication or use within the rare disease or condition for which it was designated, the product generally will be receiving orphan product exclusivity. Orphan product exclusivity means that the FDA may not approve any other applications for the same product for the same indication for seven years, except in certain limited circumstances. Competitors may receive approval of different products for the indication for which the orphan product has exclusivity and may obtain approval for the same product but for a different indication. If a drug or drug product designated as an orphan product ultimately receives marketing approval for an indication broader than what was designated in its orphan product application, it may not be entitled to exclusivity.

阿斯利康以50.5%的市占率成为这一市场的头名。其产品Zoladex, Casodex, Arimidex和Faslodex2008年销售额46亿美元。其丰富的产品线确保占据市场第一位位置。

Jadad, A. R. et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?Control Clin Trials 17, 1–12 (1996).

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Weighted unrestricted maximum likelihood meta-regression analysis was performed to assess the impact of potential moderators on the pooled effect size. None of the moderator parameters i.e. statin dose (slope: − 0.003; 95%CI: − 0.006 to 0.001; p = 0.164), duration of statin therapy (slope: 0.001; 95%CI: − 0.008 to 0.011; p = 0.774) and baseline ADMA concentrations (slope:  − 0.083; − 0.275 to 0.109; p = 0.399) was significantly associated with the pooled estimate of the statin effect on plasma ADMA concentrations. Meta-regression bubble plots are illustrated in Supplementary Figure S1.

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        At execution and the end of each reporting period, the transaction price allocated to the single performance obligation included the $4.5 million technology license fee received and the payments for research and development services expected to be received by the Company. At execution, none of the pre-clinical, clinical or regulatory milestones has been included in the transaction price, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that the receipt of the milestones is outside the control of the Company and contingent upon success of future pre-clinical and clinical studies and Merck’s efforts. The $0.5 million, $3.0 million and $2.5 million pre-clinical milestone payments received to date were added to the transaction price in the fourth quarter of 2013, the second quarter of 2016, and the fourth quarter of 2018, respectively, when they were considered probable of being reached. The Company recognized revenue under the Merck Agreement over time as it satisfied the combined performance obligation during the research term. The research term ended in April 2016 and the Company does not have any future performance obligations under this contract. At the end of each reporting period, the Company continues to assess the probability of achievement of the remaining pre-clinical, clinical or regulatory milestones and any related constraint and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments to the transaction price will be recorded as revenue in the period of adjustment.

there is no need to quench azide in situ with nitrite in the reaction mix with the product – they could have done it with mother liquors after acidification and precipitating the product, it is just that the process people are paranoid about the safety and they wanted avoid any chance of hydrazoic acid vapors – literaly a headache-causing problem for the operators who have to filter the stuff on scale