In the 1970s, there was a lot of interest in controlled-release research for pharmaceutical applications. Much of this activity focused on the development of long-acting contraceptives. The goal was to develop formulations that released contraceptive steroids at a programmed rate for one month or longer following a single parenteral administration. Initially, researchers in the contraception field used non-biodegradable silicone materials as controlled-release excipients (2). PLG polymers were later found to have good biocompatibility and desirable bioabsorption properties; as a result, many investigators began to formulate contraceptive steroids with PLG as functional polymers. Various dosage forms, including injectable microparticles, implants, and fibers, were investigated for both systemic and local delivery (3).

        In October 2016, the Company’s stockholders approved the 2016 Employee Stock Purchase Plan (the "2016 ESPP"), which gives eligible employees the right to purchase shares of common stock at the lower of 85% of the fair market value on the first or last day of an offering period. There were 175,000 shares of common stock initially reserved for issuance pursuant to the 2016 ESPP. The number of shares of common stock that may be issued under the 2016 ESPP will automatically increase on each January 1 equal to the lesser of: (i) 300,000, (ii) 1% of the Company’s shares of common stock outstanding on the immediately preceding December 31 or (iii) an amount determined by the administrator of the 2016 ESPP appointed by the Company’s board of directors. During the years ended December 31, 2018 and 2017, the Company issued 6,326 and zero shares of common stock under the 2016 ESPP, respectively. As of December 31, 2018, there were 620,401 shares available for future grant under the 2016 ESPP and on January 1, 2019, this number increased by 300,000 shares.

There were no statistically significant differences among the three treatment groups for any of the secondary end points. There was a non-statistically significant trend of mild weight reduction (P=.1) in the high dose Aramchol group. Serum adiponectin levels increased (0.2 ± 1.7 µg/mL) in the high-dose Aramchol group but decreased in the low-dose (-0.3 ± 1.5 µg/mL) and placebo groups (-0.7 ±_1.3 µg/mL) (P= 0.88 for trend of dose-response relationship by linear regression). FMD increased non-statistically significantly by 1.28% ± 2.92% in the high-dose group, by 0.34% ±3.54% in the low-dose group, and by 0.46% ± 2.28% in the placebo group. 

        Valuation methodologies used for assets measured or disclosed at fair value are as follows:

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

A further challenge to Aramchol’s market penetration is that currently a liver biopsy is the standard approach for measuring improvement in NASH patients. Because it would be impractical to subject all patients that take Aramchol, when and if it approved, to regular and repeated liver biopsies, it will be difficult to demonstrate Aramchol’s effectiveness to practitioners and patients unless and until a reliable non-invasive method for the diagnosis and monitoring of NASH becomes available, as to which there can be no assurance.

First China Pharmaceutical Group, Inc. (OTCBB:FCPG) aims to develop a high growth pharmaceutical distribution company generating significant revenue from the sale of healthcare products in China. As part of its business strategy, the Company has acquired the assets of Kun Ming Xin Yuan Tang Pharmacies Co. Ltd. (XYT), which includes a strategic advantage over its competitors as it is one of a handful of pharmaceutical distribution companies in Yunnan Province that has obtained government approval to market and fill orders using the internet. First China Pharmaceutical Group plans to continue the rapid growth of the company from its current position as a provider of approximately 7,100 drugs to more than 4,700 pharmacies, hospitals and clinics in China’s Yunnan Province.

Brusselmans, K. et al. Heterozygous deficiency of hypoxia-inducible factor-2alpha protects mice against pulmonary hypertension and right ventricular dysfunction during prolonged hypoxia. J. Clin. Invest. 111, 1519–1527 (2003).

        These developments, or the perception that any of them could occur, have had and may continue to have a material adverse effect on global economic conditions and the stability of global financial markets, and could significantly reduce global market liquidity and restrict the ability of key market participants to operate in certain financial markets. Lack of clarity about future U.K. laws and regulations of medicine as the U.K. determines which E.U. laws to replace or replicate in the event of a withdrawal, including financial laws and regulations, tax and free trade agreements, intellectual property rights and employment laws, could decrease foreign direct investment in the U.K., increase costs, and could depress economic activity and restrict our access to capital. If the U.K. and the E.U. are unable to negotiate acceptable withdrawal terms or if other Member States pursue withdrawal, barrier free access between the U.K. and other Member States or among the European economic area overall could be diminished or eliminated. Additionally, political instability in the E.U. as a result of Brexit may result in a material negative effect on credit markets and foreign direct investments in the E.U. and U.K. This deterioration in economic conditions could result in increased unemployment rates, increased short and long term interest rates, consumer and commercial bankruptcy filings, a decline in the strength of national and local economies, and other results that negatively impact household incomes. Any of these factors could have a material adverse effect on our business, financial condition and results of operations.

AmStem Corporation (OTCBB: AMST) is in the field of regenerative medicine and is a leading provider of biotherapeutic and cosmetic stem cell products, stem cell collection and storage expertise and access to nanotechnology vital to stem cell research. AmStem owns and operates two subsidiaries: a.) 90% interest of Histostem Co. Ltd. (Korean Corporation) b.) 100% control of AmStem International, Inc. (Nevada Corporation). Histostem is a producer of stem cells utilizing proprietary technology that successfully isolate stem cells from umbilical cord blood (UCB) and nurture them to multipotent stem cells. Histostem also manufactures stem cell based facial creams, possesses storage facilities and conducts clinical research. AmStem International distributes stem cell based cosmetic products.

We expect our research and development expenses to increase in the future from current levels as we continue to advance of our clinical product development into a pivotal stage trial and, potentially, the in-licensing of additional product candidates.

the birth control pills, which are being used for over 60 years, contain a progestin/estrogen combination. The positive effect of this combination was serendipitously discovered because of contamination of the first clinical batches of the progestin norethynodrel, which had to be clinically tested as ‘pure’ progestin for birth control.