Other legislative changes have been proposed and adopted in the U.S. since the ACA was enacted. For example, in August 2011, the Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2027 unless additional Congressional action is taken. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

        We believe that our application of the following accounting policies, each of which require significant judgments and estimates on the part of management, is the most critical to aid in fully understanding and evaluating our reported financial results: (1) revenue recognition, (2) research and development costs, and (3) stock-based compensation.

The SPSS version 18.0 (Chicago, IL, USA) software was used in the statistical analysis. The data were expressed as means ± SD and p < 0.05 was considered statistically significant. Tukey was used to determine differences between groups.

HIF-dependent gene regulation was performed by a dual reporter gene assay, using a firefly luciferase construct and a reference Renilla luciferase construct pRL-TK (Promega, Madison, WI). A putative promoter of miR-322 containing the consensus sequence of the HRE was constructed by PCR from rat genomic DNA by using the primers: 5- CCG CTC GAG TAC TTA GTT TAA CTA CAG ACT C -3 (forward) and 5- CGA CGC GTG GGG CCG CTC TGG GGT ACC TGC -3 (reverse). Luciferase activity was measured in cell extracts with a Lumat LB9508 luminometer (Berthold, Bad Wildbad, Germany).

        If unacceptable side effects arise in the development of our product candidates, we, the FDA or comparable foreign regulatory authorities, the Institutional Review Boards, or IRBs, or independent ethics committees at the institutions in which our studies are conducted, or the Data Safety Monitoring Board, or DSMB, could suspend or terminate our clinical trials or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We expect to have to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death. Any of these occurrences may harm our business, financial condition and prospects significantly.

Beck, A., Kolisek, M., Bagley, L. A., Fleig, A. & Penner, R. Nicotinic acid adenine dinucleotide phosphate and cyclic ADP-ribose regulate TRPM2 channels in T lymphocytes. FASEB. J. 20, 962–964 (2006).

Pursuant to the Companies Law and regulations promulgated thereunder with respect to the convening of general meetings in a public company, shareholder meetings generally require prior notice of not less than 21 days, and for certain matters specified in the Companies Law, not less than 35 days. The function of the annual general meeting is to elect directors in accordance with the Articles, receive and consider the profit and loss account, the balance sheet and the ordinary reports and accounts of the directors and auditors, appoint auditors and fix their remuneration and transact any other business which under the Articles or applicable law may be transacted by the shareholders of a company in general meeting.

The first study that showed that middle-aged smoking men in the highest quartile of ADMA levels were at an almost 4-fold risk for acute coronary events was conducted in 20015. Since then, it has been shown that higher ADMA levels are related to increased mortality and adverse clinical outcomes in patients with coronary artery disease (CAD), diabetes, renal disease and ischemic stroke6,7,8,9. Moreover, in the Coronary Artery Risk Determination investigating the Influence of ADMA Concentration (CARDIAC) study, ADMA was shown to be a risk factor for CAD, independently of traditional predictors10.

Marketable debt securities are considered to be available for sale and are carried at fair value. Unrealized gains and losses net of tax, if any, are reported as a separate component of stockholders’ equity. The cost of marketable debt securities classified as available for sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses and declines in value judged to be other than temporary, if any, are also included in other income, net. Interest on securities classified as available for sale is included in interest income. The cost of securities sold is based on the specific identification method.

Licensing revenue amounted to $2.0 million during the year ended December 31, 2018, compared to $1.1 million of revenue for the year ended December 31, 2017. The above-mentioned revenue resulted from the amortization of the upfront payment and a $1.5 million milestone payment received under the Samil Agreement.

So Josh, as if right on cue with your post , this study of aspirin and cancer came out today from the Chinese University of Hong Kong, Kelvin Tsoi presented it at the United European Gastrenterology meeting in Barcelona. They looked at 600,000 people over 10 years. Of these, 206,295 were ASA users. Average age 67.5 years, median dose 80mg and average duration 7.7 years. The team followed outcomes for up to 14 years looking for cancer incidences. About 16% developed cancer, withlung being the most prevalent. So here it is, the ASA users were: 47% less likely to have liver and esophageal cancer 38% less likely to have stomach cancer 34% less likely pancreatic cancer 24% less colon Also significant reduction in leukemia, lung and prostate cancers Wow

Our R&D Committee, which was established by the Board on May 2014, advises and assists the Board in its oversight of our research and development programs, including the rationale and timeline of clinical trials and other studies, as well as market surveys in connection therewith. The R&D Committee operates in accordance with the purposes and objectives determined by the Board from time to time. Dr. Sidransky, Dr. Oren and Dr. Brosgart are the current members of our R&D Committee, with Dr. Sidransky serving as chairperson.