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        Third, the FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA determines, on a case-by-case basis, whether the proposed product represents a significant improvement when compared with other available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting adverse reaction, documented enhancement of patient compliance that is expected to lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation. A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application from ten months to six months.

This study was supported in part by National Natural Science Foundation of China No. 81170047 and 81370151 (to D.G.); National Basic Research Program of China (973 Program, 2012CB124701) and Shenzhen overseas high-level talents innovation program No. YFZZ20111009 (to D.G.).

Even if Aramchol, or any future product candidates that we may develop, receives marketing approval, we will continue to face extensive regulatory oversight and requirements, and any such product may still face future regulatory risks or new requirements.

On December 13, 2018, our Board resolved to increase Mr. Baharaff’s gross monthly salary to 144,375 NIS per month, commencing January 1, 2019 with such increased salary to be in effect for a period of two years. Implementation of the increase is subject to shareholder approval and is still pending.

The product liability insurance we will need to obtain in connection with the commercial sales of Aramchol and any future product candidates, if and when they receive regulatory approval, may be unavailable in meaningful amounts or at a reasonable cost. If we are the subject of a successful product liability claim that exceeds the limits of any insurance coverage we obtain, we would incur substantial charges that would adversely affect our earnings and require the commitment of capital resources that might otherwise be available for the development and commercial launch of Aramchol and any future product candidate’s programs.

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(a) Differential expression of 1040 miRNAs in lung tissue from mice exposed to normoxia (21% O2)(Con) or hypoxia (10% O2) for 2 days (H-2D), 1 week (H-1W), 2 weeks (H-2W) and 3 weeks (H-3W) (n = 3 or 4 for each group). Cluster analysis of miRNAs expression from individual specimens were assessed by microarray analysis. (p < 0.05 compared with normoxic controls). (b) Validation of miRNAs upregulated by hypoxia by real-time PCR assay. Bar charts showing the relative expression level by normalizing to the respective normoxia control (Con). Data are shown as means ± SD, *p < 0.05, **p < 0.01. (c) Hypoxia results in stabilization of HIF-1α and HIF-2α proteins in the lung. Representative immunoblots showing the lung HIF-1α and HIF-2α levels in normoxia and hypoxia-exposed mice. β-actin levels served as loading control. The full-length blots with these antibodies were presented in supplementary Figure S1. All gels have been run simultaneously under the same experimental conditions.

        Further, although our reliance on these third parties for clinical development activities limits our control over these activities, we remain responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards. For example, notwithstanding the obligations of a CRO for a trial of one of our product candidates, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with requirements, commonly referred to as good clinical practices, or GCPs, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. The FDA enforces these GCPs through periodic inspections of trial sponsors, principal investigators, clinical trial sites and IRBs. If we or our third-party contractors fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving our product candidates, which would delay the marketing approval process. We cannot be certain that, upon inspection, the FDA will determine that any of our clinical trials comply with GCPs. We are also required to register clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

As of December 31, 2018, and 2017, the weighted-average remaining contractual term of the outstanding and exercisable options, excluding the 38,637 options granted in 2002 that have no expiration date, is 7.29 and 6.95 years, respectively.

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.

        Our common stock has been trading on The Nasdaq Global Market under the symbol "RARX" since it began trading on October 26, 2016. Prior to this date, there was no public market for our common stock.