Amarillo Biosciences Inc. (OTCBB: AMAR ) Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which owns 10.5% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments to the company. Amarillo Biosciences’ primary focus involves extensive and ongoing R&D into the utilization of low-dose, orally administered interferon as a treatment for a variety of conditions, including chronic cough (COPD), influenza, and opportunistic infections in patients who are HIV positive. In its 23-year history, the Company has invested nearly $39 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for low-dose oral interferon.

FDA and EMA have emphasized that patients who continue to take medications that may contain these impurities face very low risks of developing serious health problems. In August 2018, FDA scientists said that it would take 8000 patients taking the maximum daily dose of the drug (320 mg) each day for four years, to result in one additional case of cancer (6). Regulatory agency officials have asked that patients remain on these medications until their physicians prescribe alternatives. 

The Affordable Care Act, enacted in March 2010, has had a significant impact on the health care industry. Some of the key changes made to date pursuant to the Affordable Care Act include an expansion of coverage for the uninsured, the creation of insurance marketplaces and increased protection of insureds with new benefits, rights and protections. With regard to pharmaceutical products, among other things, the Affordable Care Act made major changes to the Medicare prescription drug program, which helped reduce drug costs for seniors and increased rebates and other costs for the pharmaceutical industry.

Machado, R. D. et al. Mutations of the TGF-beta type II receptor BMPR2 in pulmonary arterial hypertension. Hum. Mutat. 27, 121–132 (2006).

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such a shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Pharmaceutical companies are certainly interested as well, as indicated by the numerous reports of API synthetic methods designed to be operated under continuous flow conditions. A summary of selected processes is presented in the following.

(a) Western blotting analysis of HIF-1α subcellular expression in rat PASMCs exposed to hypoxia for 24h. TBP (TATA box Binding Protein) and α-tubulin were used as internal controls for the nuclear and cytoplasmic fractions, respectively. (b) Quantitative real-time PCR quantification of miR-322 in stably transfected rat PASMCs. Cells were transfected with recombinant lentiviral particles expressing miR-322 (miR-322) or control lentiviral vector (miR-Con), or with lentivirus of dTud construct against mature miR-322 (anti-322) or scramble control vector (anti-Con). Data are shown as means ± SD relative to respective controls, *p < 0.05 compared with controls. (c) Left: Immunoblotting to determine HIF-1α expression in cells transfected with lentivirus expressing miR-322 or control lentivirus under normoxia. Right: Immunoblotting to determine HIF-1α expression in PASMCs transfected with anti-322 construct or scramble control and exposed to hypoxia. The full-length blots with these antibodies were presented in supplementary Figure S4. All gels have been run simultaneously under the same experimental conditions.

Ruwhof, C. & van der Laarse, A. Mechanical stress-induced cardiac hypertrophy: mechanisms and signal transduction pathways. Cardiovasc. Res. 47, 23–37 (2000).

If clinical trials of our product candidates fail to satisfactorily demonstrate safety and efficacy to the FDA and other regulators, we, or any future collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates.

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        If the license to the intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenue when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from the combined performance obligation. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. When we recognize revenue allocated to the license at a point in time, we may experience significant fluctuations in our revenue from quarter to quarter and year to year depending on the timing of transactions.

We cannot predict if investors will find our ordinary shares less attractive because we may rely on these exemptions. If some investors find our ordinary shares less attractive as a result, there may be a less active trading market for our ordinary shares, and our share price may become more volatile and decline.