Zilucoplan is a potent synthetic macrocyclic peptide inhibitor of C5, which is a clinically validated target for patients with PNH. We are developing zilucoplan as a convenient, self-administered product that can be administered in a small daily, or less frequent, such as weekly, dose. We believe this approach will facilitate sustained hemolysis suppression, greatly reducing the possibility of breakthrough hemolysis in eculizumab naïve and eculizumab switch patients who were transfusion-independent on eculizumab. In addition, we believe self-administration will alleviate the significant time and cost burden associated with regular intravenous infusions by healthcare professionals, as well as reduce complications associated with IV infusions, including infections, thrombosis, and loss of venous access.

If we are unable to establish, scale-up and implement improvements to our control systems in an efficient or timely manner, or if we encounter deficiencies in existing systems and controls, investors may choose not to invest in us, which could cause our share price to decline and negatively impact our ability to successfully commercialize Aramchol and any future product candidates.

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Josh, did you know that a company called Youthereum Genetics is being set up in Russia with the aim of doing epigenetic rejuvenation in humans?

Moher, D. et al. Assessing the quality of reports of randomised trials: implications for the conduct of meta-analyses. Health technology assessment (Winchester, England) 3, i-iv, 1–98 (1998).

ABBOTT LABORATORIES (NYSE: ABT ) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.

        Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Management has considered the Company’s history of operating losses and concluded, in accordance with the applicable accounting standards, that it is more likely than not that the Company will not realize the benefit of its deferred tax assets. Accordingly, with the exception of the deferred tax assets recorded at Cosmix, the deferred tax assets have been fully reserved at December 31, 2018 and 2017. Management reevaluates the positive and negative evidence on a quarterly basis.

        In addition, changes in marketing approval policies during the development period, changes in or the enactment or promulgation of additional statutes, regulations or guidance or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional pre-clinical, clinical or other studies. In addition, varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we, or any future collaborators, ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

After 1 month (30 days) of AAS, the animals were examined by echocardiography, and the rats having left ventricular wall thickness 20% thicker than that in sham group were identified as succeeded in modeling and randomly assigned either to model groups, including AAS1M and AAS2M, or drug treatment groups, including QSYQ, ASIV, DLA, R1, DO, ASIV+DLA, ASIV+R1, ASIV+DO, DLA+R1, DLA+R1+DO, and ASIV+DLA+R1 group, 6 animals in each group. The animals in AAS1M were sacrificed for assessment of parameters concerned after echocardiographic analysis. In Sham and AAS2M groups, the animals received saline daily by gavage for the succeeding 1 month at a dose of 4 mL/kg/day. Over the same period of time, the animals in drug treatment groups received indicated drugs by gavage at following doses: 0.8 g/kg/day (QSYQ), 0.528 mg/kg/day (ASIV), 3.392 mg/kg/day (DLA), 0.48 mg/kg/day (R1), and 3.2 mg/kg/day (DO). Two months after AAS, the animals were examined by echocardiography once again and then sacrificed for parameter assessment.

        The accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the product’s clinical benefit. As a result, a product candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies or confirm a clinical benefit during post-marketing studies, would allow the FDA to withdraw the product from the market on an expedited basis. All promotional materials for product candidates approved under accelerated regulations are subject to prior review by the FDA.

We conducted the food effect and PK study at the Sourasky Medical Center in Tel Aviv, Israel involving 66 healthy volunteers to evaluate the PK of Aramchol following single and multiple escalating doses (200 mg, 400 mg and 600 mg), as well as to evaluate the effect of a high-fat, high-calorie meal on the PK of Aramchol following a single dose in healthy volunteers.