Historically, we had not provided program costs because we have not tracked or recorded our research and development expenses on a program-by-program basis. Beginning in the first quarter of 2017, we began to allocate costs related to our third-party vendors directly to programs.
Liu, L. et al. Taoren – Honghua herb pair and its main components promoting blood circulation through influencing on hemorheology, plasma coagulation and platelet aggregation. J Ethnopharmacol. 139, 381–387 (2012).
Question from the peanut gallery: why isn’t a manufacturer required to sample product and test it for purity level continuously? You want quality, you monitor for quality, whether you make widgets or websites, isn’t that a truism? Even setting aside the deliberate process change, surprises happen.
Certain PNH patients acquire a genetic mutation that prevents the normal attachment of complement regulatory proteins to the membranes of blood cells. On normal cells, these proteins are critical inhibitors of complement activity and provide one means of distinguishing host cells from invading pathogens. The absence of these proteins results in the accumulation of a complement protein called C3b, which leads to cleavage of C5 and the deposition of the MAC on essentially all blood cells, including red blood cells and platelets. Red blood cells are particularly susceptible to lysis by MAC, resulting in their destruction and release of hemoglobin, leading to anemia. Uncontrolled activation of complement on platelets can promote thrombosis, which is the most common cause of death in PNH patients. Other serious and potentially life-threatening complications of PNH include high blood pressure in the lungs and damage to the kidneys.
选择性雌激素受体调节剂市场2004至2008年年降低2.5%。2008年规模为5.26亿美元,占激素治疗市场的5.8%。
We have never declared or paid cash dividends on our common stock, and we do not expect to pay any cash dividends on our common stock in the foreseeable future. Payment of future dividends, if any, on our common stock will be at the discretion of our board of directors after taking into account various factors, including our financial condition, operating results, anticipated cash needs, and plans for expansion.
(b) a person (or a relative of a person) who has the power to appoint a director or the general manager of the Company;
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting.
Changes to the patent law in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
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 lengthy process of completing clinical trials and seeking regulatory approval for Aramchol requires the expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Because of the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects.
sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.
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