Efforts to ensure that our business arrangements with third parties, and our business generally, will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, and the curtailment or restructuring of our operations. Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

We believe that the raw materials that we require to manufacture Aramchol are readily available commodities commonly used in the pharmaceutical industry.

Wang, F. et al. Expression of P311, a transforming growth factor beta latency-associated protein-binding protein, in human kidneys with IgA nephropathy. International urology and nephrology. 42, 811–819 (2010).

Li, J. et al. Blockade of endothelial-mesenchymal transition by a Smad3 inhibitor delays the early development of streptozotocin-induced diabetic nephropathy. Diabetes. 59, 2612–2624 (2010).

As of December 31, 2018, 16.994 restricted stock units (RSUs) granted to our Office Holders as a group were outstanding. For outstanding equity-based awards granted to our Office Holders, see below under “Item 6. Directors, Senior Management and Employees—E. Share Ownership—Certain Information Concerning Equity Awards to Office Holders.”

There may be other reasons to prefer one or another NSAID.  There are benefits for joint pain and stiffness; there are risks for gastric pain and ulcers.  It’s an individual choice, and I encourage you to experiment on yourself.  You can alternate different NSAIDs, but it’s best to do so week-by-week or month-by-month, rather than daily.  Don’t take aspirin and other NSAIDs in the same week.

Hi Mark When have no distinction between science and science fiction; it undermines science. Science is not whatever somebody pulls out of their butt.

        There have been a number of federal and state proposals during the last few years regarding the pricing of pharmaceutical and biopharmaceutical products, government control and other changes to the healthcare system in the U.S.

These are variants of vitamin E.  They differ from vitamin E (tocopherol) in the same way that unsaturated fats differ from saturated fats.  They are more reactive, more easily manipulated by the body.  The normal varieyty of vitamin E (alpha tocopherol) does not have lifespan benefits, and may be a net negative.  Gamma tocopherol may be better, or it may be that we need a mixture of tocopherols in combination. The only human studies have been done with alpha tocopherol, and when you buy “vitamin E pills” that’s what you’re getting.

Kolwicz, S. C., Jr. & Tian, R. Glucose metabolism and cardiac hypertrophy. Cardiovasc. Res. 90, 194–201, 10.1093/cvr/cvr071 (2011).

“Doesn’t the FDA have to approve all changes to manufacturing before the product can be sold?” Yes, that’s correct, but generally according to the ICH Q3 model, there is a threshold for inclusion in a specification, which is the ID threshold, and another threshold for qualification UNLESS there is deemed to be some special toxicity like genotox.

Angiotech Pharmaceuticals, Inc . ( NASDAQ: ANPI , TSX: ANP ) is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury.