As a toxicologist, I’ll note that N-nitrosodiethylamine is a carcinogen to be concerned about. Now, agencies like EPA and IARC label virtually anything as carcinogenic, it can be hard to decide what to be concerned about. Most nitrosamines are very dangerous.

The weighted average grant date fair value of the options granted during the years ended December 31, 2018, 2017 and 2016 is $8.19, $4.86, and $3.76 respectively.

Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the U.S. and require us to develop and implement costly compliance programs.

In the recently completed ARREST Study that enrolled 247 NASH patients with biopsy-proven NASH who were overweight or obese and had pre-diabetes or type II diabetes mellitus, serious adverse events were reported in 12.5%, 8.9% and 9.2% of patients in placebo, Aramchol 400mg and 600mg arms, respectively. No clustering of event type or atypical events for the studied population were reported in either Aramchol arms. Early terminations due to adverse events occurred in 4.2%, 3.0% and 4.1% in placebo, Aramchol 400mg and 600mg arms, respectively. Most frequent adverse events included headaches, UTI, pruritus, nausea, influenza, constipation and fatigue.

Our operating loss for the year ended December 31, 2017 was approximately $12.4 million, representing a decrease in our operating loss of approximately $4.5 million, or approximately 27%, compared to approximately $16.9 million for the year ended December 31, 2016.

        We, or any future collaborators, may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent clinical development, marketing approval or commercialization of our product candidates, including:

Meng, X. M. et al. Smad2 protects against TGF-beta/Smad3-mediated renal fibrosis. Journal of the American Society of Nephrology : JASN. 21, 1477–1487 (2010).

We determined that the transaction price at contract inception was $2.1 million consisting of the upfront, non-refundable payment. None of the clinical or regulatory milestones were included in the transaction price upon inception, as all milestone amounts were fully constrained. Management assessed that the likelihood of occurrence of the other performance obligations in the Samil Agreement was remote upon contract inception. As such, the standalone value of such performance obligations was deemed de minimis and none of the transaction price was allocated to those obligations. Any consideration related to sales-based milestones and royalties will be recognized when the related sales occur, and therefore have also been excluded from the transaction price.

        There are a number of currently marketed products and product candidates in pre-clinical research and clinical development by third parties to treat the various diseases that we are targeting. In general, these products and product candidates can be categorized based on their proposed mechanisms of action. The mechanisms of action for these product candidates include inflammation suppression by agents such as complement inhibitors and corticosteroids, as well as immune modulators, visual cycle modulators, anti-amyloid agents, antioxidants, neuroprotectants, cell and gene therapies, and vascular and interstitial tissue remodeling agents.

We generally enter into non-competition agreements with our employees and certain key consultants, or our employment and consulting agreements contain non-competition provisions. These agreements, to the extent they are in place and in effect, prohibit our employees and certain key consultants, if they cease working for us, from competing directly with us or working for our competitors or clients for a limited period of time. We may be unable to enforce these agreements under the laws of the jurisdictions in which our employees work and it may be difficult for us to restrict our competitors from benefitting from the expertise our former employees or consultants developed while working for us. For example, Israeli courts have required employers seeking to enforce non-compete undertakings of a former employee to demonstrate that the competitive activities of the former employee will harm one of a limited number of material interests of the employer which have been recognized by the courts, such as the secrecy of a company’s confidential commercial information or the protection of its intellectual property. If we cannot demonstrate that such interests will be harmed, we may be unable to prevent our competitors from benefiting from the expertise of our former employees or consultants and our ability to remain competitive may be diminished.

According to Blagosklonny aging theory mTOR drives aging and age related disease. MTOR driving growth causes resting cells to become senescent cells. So Rapamycin is used to reduce mTOR to reduce Hyperfunction and mTOR driving growth. In regard to great minds noted in previous comments; I would place Blagosklonny on same level as Charles Darwin. Problem is, everybody wants to be an Indian Chief and everybody has their own theory.

Bryceson, Y. T. et al. Defective cytotoxic lymphocyte degranulation in syntaxin-11 deficient familial hemophagocytic lymphohistiocytosis 4 (FHL4) patients. Blood 110, 1906–1915 (2007).