Klein-Nulend, J., van Oers, R. F. M., Bakker, A. D. & Bacabac, R. G. Nitric oxide signaling in mechanical adaptation of bone. Osteoporosis Int. 25, 1427–1437 (2014).

I agree that we were just speculating. On my side, it is based on nothing. It is not science at all (again on my side). Just having fun. Maybe we should not do that here. I’ll try to be more careful.

the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients. The FDA will typically inspect one or more clinical sites to assure compliance with GCP and the integrity of the clinical data submitted.

We have invested almost all of our efforts and financial resources in the research and development (clinical and pre-clinical) of our product candidate, Aramchol. We recently completed our Phase 2b ARREST Study, or the ARREST Study and are planning to initiate the ARMOR Study of Aramchol in 2019. As a result, our business is largely dependent on the commencement of and success of the ARMOR Study and our ability to complete the development of, obtain regulatory approval for and successfully commercialize Aramchol in a timely manner. The commencement of the ARMOR Study is dependent, in part, upon the success of our end of Phase 2b meeting that we plan to hold with the FDA during March 2019 and agreement on an IND for the ARMOR Study that, dependent on the outcome of that meeting, we plan to file with the FDA. There can be no assurance regarding the outcome of the planned end of Phase 2b meeting with the FDA or the IND. The process to develop, obtain regulatory approval for and commercialize Aramchol is long, complex, costly and uncertain as to its outcome.

On February 2, 2014, we underwent the Reorganization, pursuant to which all of our intangible assets (including our intellectual property) were transferred from GIL to GRD. The Reorganization was effectuated by share transfers and asset transfers, resulting in the Company as the parent company and 100% equity-owner of the following companies: (1) GRD, which holds all the Group’s intellectual property, including the Company’s patent portfolio; (2) GIL, which is an inactive company; and (3) GTTI, which was liquidated in 2017. GIL holds GMR, which became an inactive company in 2015 and was liquidated in February 2019. The Reorganization was conducted in order to simplify our capital structure, reduce our operating cost and to improve our ability to raise funds. Immediately prior to the Reorganization, all our shareholders collectively held 9,739 ordinary shares of GHI. In connection with the Reorganization, and in accordance with the Tax Pre-Ruling, we issued to all such shareholders ordinary shares of the Company, such that upon the Reorganization all our shareholders collectively held 7,099,731 ordinary shares of the Company, in the same proportion among all shareholders, which reflected a ratio of 729 ordinary shares of the Company for each ordinary share of GHI.

Advanced Cell Technology Inc. (OTCPK:ACTC ) Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine with its laboratory located in Worcester, Massachusetts.

Genetic Technologies (ASX:GTG.AX ; NASDAQGM: GENE ) specializes in licensing, genetic testing and research. GTG’s exclusive access to a wide range of genetic tests enables it to expand its testing services throughout the Asia-Pacific region. GTG’s pipeline of innovative research projects will potentially add considerable value to its licensing and genetic testing businesses.

Palmer, R. M., Ferrige, A. G. & Moncada, S. Nitric oxide release accounts for the biological activity of endothelium-derived relaxing factor. Nature. 327, 524–526 (1987).

        We have never commercialized a product, and even if one of our product candidates is approved by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. Physicians are often reluctant to switch their patients from existing therapies even when new and potentially more effective or convenient treatments enter the market. Further, patients often acclimate to the therapy that they are currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch therapies. Even if we are able to obtain marketing approval of zilucoplan for the treatment of complement mediated diseases, physicians and patients may decide not to switch to zilucoplan. In addition, even if we are able to demonstrate our product candidates’ safety and efficacy to the FDA and other regulators, safety concerns in the medical community may hinder market acceptance.

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.

Even the Chinese manufacturing process for acetaminophen (a.k.a. paracetamol) is a point of concern, says André, since one of the early intermediates is the probable carcinogen, 1-chloro-4-nitrobenzene. “We have audited most of the major Chinese manufacturing plants of acetaminophen, and found no evaluation of and no testing for 1-chloro-4-nitrobenzene at any of them,” he says. André sees a need for manufacturers and regulators to pay much closer attention to potential risks in the manufacturing process. “In the valsartan case, the focus was on control of the related substances of synthesis and other impurities above the reporting threshold (0.05% in the case of valsartan), rather than on the safety of the chemical synthesis processes.

The study is currently designed to consist of two parts. In the first part (histology-based) subjects will undergo biopsy, followed by treatment with Aramchol or matching placebo for 52 weeks until the second biopsy. The primary histology-based endpoint is expected to be NASH resolution without worsening of fibrosis or fibrosis improvement without NASH worsening.