Hi Heather Interesting post about Iscador. I had never heard of it . You wouldn’t believe the things I hear at least once a week. A guy with a crazy high prostate cancer PSA reading said that his level completely normalized using 1 gram of cbd oil a day from hemp. Who knows? There is a fascinating study showing multiple anti-cancer pathways of cannabidiol.

        The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, each as amended, or collectively the Affordable Care Act, or ACA, contains many provisions of potential importance to our business and our product candidates are the following, including among others:

Pevsner-Fischer, M., Levin, S. & Zipori, D. The origins of mesenchymal stromal cell heterogeneity. Stem. Cell. Rev. 7, 560–568 (2011).

        We meet the Securities and Exchange Commission’s ("SEC’s") definition of a "Smaller Reporting Company," and therefore qualify for the SEC’s reduced disclosure requirements for smaller reporting companies.

On July 28, 2016, the Company entered into a license agreement ("Samil Agreement") with Samil Pharm. Co., Ltd. (the “Samil”), for an exclusive, royalty-bearing license for the commercialization of Aramchol (with an option to manufacture) for the treatment of fatty liver indications including NASH in the Republic of Korea. Additionally, following the ARREST Study, Samil has an option to extend the License to Vietnam, which, if exercised, would increase the clinical- and regulatory-based milestone payments.

The following table sets forth our selected consolidated financial data for the periods ended and as of the dates indicated, which reflects the financial data of the Company and the financial data of Galmed Holdings Inc., a holdings company incorporated in the British Virgin Islands, or GHI, our predecessor, prior to the Reorganization (as described below). The following selected consolidated financial data for our Company should be read in conjunction with the financial information, “Item 5. Operating and Financial Review and Prospects” and other information provided elsewhere in this annual report and our consolidated financial statements and related notes. The selected consolidated financial data in this section is not intended to replace the consolidated financial statements and is qualified in its entirety thereby. In the opinion of our management, our unaudited consolidated financial statements contain all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of our financial position, results of operations and cash flows as of and for the periods indicated therein.

Treatment of CHO-K1 cells expressing human HCN1 channels by MβCD resulted in reduced current density compared to untreated control cells (Fig. 1A,B). To verify that this effect was specific to the effects of membrane cholesterol, and not due to unspecific effects of MβCD, we also examined the effect of 30 μM mevastatin, which blocks cholesterol synthesis. Similar to the effect of MβCD, current densities were also reduced in cells treated with mevastatin. While there was a trend towards an increase in the current density with the enrichment of cellular cholesterol by MβCD/cholesterol (P = 0.12), statistical significance could not be resolved. Both depletion and enrichment had no effect on the steady-state activation properties of HCN1 channels (Fig. 1C; Table 1). HCN1 activation currents can be described by a dual-exponential function, whose fast time component (τfast) was unchanged by modulation of membrane cholesterol (Fig. 1D), however, cholesterol depletion reduced the slow component of activation (τslow) by 2-fold (Fig. 1E). No observable effect on HCN1 deactivation kinetics could be discerned.

        In addition to the protection afforded by patents, we also rely on trade secret protection for certain aspects of our intellectual property. For example, a majority of the patents underlying our proprietary peptide chemistry technology expire by 2022. As a result, we anticipate that we will rely on trade secrets as the primary protection for the know-how behind our proprietary platform. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, consultants, independent contractors, advisors, contract manufacturers, suppliers and other third parties. We also enter into confidentiality and invention or patent assignment agreements with employees and certain consultants. Any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary

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finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of the product candidate or findings of undesirable effects caused by a chemically or mechanistically similar product or product candidate;

We are conducting a global development program for Aramchol for the treatment of NASH in patients who are overweight or obese and have pre diabetes or type II diabetes mellitus, and we may make our submissions for regulatory approval in parallel; initially in Europe and in the United States. Typically, approval time in the United States with the FDA for an NDA is faster than that within Europe with the EMA and the European Commission for an MAA, especially when the novelty of the submission is considered. First in class, high medical need and rare disease drugs can experience faster review. Nevertheless, marketing and pricing approval presents a further delay in many countries that should be considered in addition to the regulatory approvals noted above.

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