That is not to say I do not trust generics generally. There are really good generic producers, and there are, to put it politely, not so good ones. I only buy generic medicines from the good guys (rather, those ones I know to be good).

BioCancell Therapeutics, Inc (Tel Aviv: BICL.TA ) is a biotechnology company specializing in the development of patient oriented targeted therapy for the treatment of a wide range of cancers. Its therapeutic and diagnostic technology, BC-819, constitutes a search and destroy paradigm for the targeted destruction of cancer cells with no effect on surrounding tissue and no observed side effects for long-term, safe treatment and prevention of cancer. The patient oriented targeted therapy approach is based on the identification of particular genes that are highly expressed only in tumors. BioCancell Therapeutics Inc. holds granted and pending patents including the use of the H19 gene as a tumor marker, methods and compositions for inducing tumor-specific cytotoxicity, method for detection of micro-metastasis, H19 siRNA and methods and composition for inducing selective expression in tumor cells of the A subunit of the Diphtheria Toxin and the TNF alpha genes under the control of H19 promoter (H19 + TNF alpha).

Lu, T. M. et al. Effect of rosuvastatin on plasma levels of asymmetric dimethylarginine in patients with hypercholesterolemia. The American journal of cardiology 94, 157–161, doi: 10.1016/j.amjcard.2004.03.052 (2004).

We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position, results of operations or cash flows due to adverse changes in financial market prices and rates, including interest rates and foreign exchange rates, of financial instruments.

We apply ASC 718-10, “Share-Based Payment,” which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors, including employee stock options under the Company’s stock plans, based on estimated fair values. ASC 718-10 requires companies to estimate the fair value of equity-based payment awards on the date of the grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in the Company’s consolidated statement of operations. The foregoing estimates of fair value that the Company has made are highly complex and subjective. The estimates of the fair value of the Company’s ordinary shares will not be necessary to estimate the fair value of new awards as the shares started trading on the Nasdaq Capital Market as of March 2014.

Any lawsuits relating to infringement of intellectual property rights necessary to defend ourselves or enforce our rights will be costly and time consuming.

According to a 2018 Reuters analysis of national medicines agencies’ records, more than 50 companies around the world have recalled valsartan mono-preparations or combination products manufactured from the tainted valsartan ingredient. The contamination has likely been present since 2012 when the manufacturing process was changed and approved by EDQM and FDA authorities. Based on inspections in late 2018, both agencies have suspended the Chinese and Indian manufacturers’ certificates of suitability for the supply of valsartan in the EU and the US.[23]

On July 28, 2016, we entered into a license agreement, referred to herein as the Samil Agreement, with Samil for the commercialization of Aramchol (with the option to manufacture) in the Republic of Korea, or the Territory.

Aoxing Pharmaceutical Company (AMEX:AXN) is a US incorporated specialty pharmaceutical company with its operations in China, specializing in research, development, manufacturing and distribution of a variety of narcotics and pain-management products. Headquartered in Shijiazhuang City, outside Beijing, Aoxing has the largest and most advanced manufacturing facility in China for highly regulated narcotic medicines. Its facility is one of the few GMP facilities licensed for the manufacture of narcotic medicines by the China State Food and Drug Administration (SFDA). It has a joint venture collaboration with Johnson Matthey Plc to produce and market narcotics and neurological drugs in China. It also has strategic alliance partnership with QRxPharma, Phoenix PharmaLabs, Inc and American Oriental Bioengineering, Inc.

        Share-based compensation is recognized as an expense in the financial statements based on the grant date fair value over the requisite service period. For awards granted to employees and directors that vest based on service conditions, the Company uses the straight-line method to allocate compensation expense to reporting periods.

Sutendra, G. et al. A metabolic remodeling in right ventricular hypertrophy is associated with decreased angiogenesis and a transition from a compensated to a decompensated state in pulmonary hypertension. J. Mol. Med. 91, 1315–1327, 10.1007/s00109-013-1059-4 (2013).

To date, we have not generated revenue from the sale of any product, excluding the licensing revenue we recorded in connection with the Samil Agreement, and we do not expect to generate any significant revenue other than the amortization of the upfront payments under the license agreement with Samil and of the subsequent royalties and/or milestones that may be earned in connection with the Samil Agreement or potential other license Agreements, unless and until we commercialize Aramchol, or license the product to additional third parties. As of December 31, 2018, the Company had an accumulated deficit of approximately $86.5 million.