It is very difficult, but it is sometimes possible to protect yourself but still alert third parties to some problems. The WSJ exposed problems at Theranos (Dx, not Tx). Some legislators can be contacted.

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        Developing pharmaceutical products, including conducting pre-clinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception. As of December 31, 2018, our cash and cash equivalents were $209.8 million. In February 2018 and December 2018, we raised an additional $54.1 million and $140.2 million, respectively, in net proceeds in our underwritten public offerings. Our research and development expenses were $54.5 million and $45.3 million for the years ended December 31, 2018 and 2017, respectively. We expect our expenses to increase in connection with our ongoing activities, particularly as we initiate new clinical trials of, initiate new research and pre-clinical development efforts for and seek marketing approval for, our current or future product candidates or any product candidates that we acquire, if any. In addition, if we obtain marketing approval for any of our product candidates, we may incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of a future collaborator. Furthermore, as a public company, we will incur significant additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we may be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.

        Third, the FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA determines, on a case-by-case basis, whether the proposed product represents a significant improvement when compared with other available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting adverse reaction, documented enhancement of patient compliance that is expected to lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation. A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application from ten months to six months.

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Moncada, S., Higgs, E. A. & Vane, J. R. Human arterial and venous tissues generate prostacyclin (prostaglandin x), a potent inhibitor of platelet aggregation. Lancet. 1, 18–20 (1977).

In addition to regulations in the United States, the EU and Israel, we are subject to a variety of other regulations governing clinical trials and commercial sales and distribution of drugs in other countries. Whether or not Aramchol or any future product candidates receive approval from the FDA, approval of such product candidates must be obtained by the comparable regulatory authorities of countries other than the United States before we can commence clinical trials or marketing of the product in those countries. The approval process varies from jurisdiction to jurisdiction, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials and product licensing vary greatly from country to country.

        4.     The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

Shmuel Nir, a director of the Company since 2007, serves as President and Chief Executive Officer of Tushia Consulting Engineers Ltd., an investment and management services company. From January 2001 to January 2016, Mr. Nir served as Chairman of the board of directors of Matan Digital Printers Ltd. From March 1998 to January 2008, he served as President and Chief Executive Officer of Macpell Industries Ltd., a leading industrial group. Between January 1991 and March 1998, Mr. Nir was an Executive Vice President of Operations at Macpell Industries Ltd. and President and Chief Executive Officer of two of its subsidiaries, New Net Industries Ltd. and New Net Assets Ltd. Prior to January 1991, Mr. Nir had held various positions with Intel Corporation in Jerusalem, Israel and Tefen Management Consulting. Between 1999 and 2006, Mr. Nir served as managing partner at Spring Venture Capital Fund. Mr. Nir holds a B.Sc. in Industrial Engineering and Management from the Technion – Israel Institute of Technology in Haifa, which was awarded in 1989.

Rashkin, M. J., Hughes, R. M., Calloway, N. T. & Waters, M. L. Orientation and alkylation effects on cation-π interactions in aqueous solution. J. Am. Chem. Soc. 126, 13320–13325 (2004).

(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.

Also striking was the isoform specific effect on hysteretic behaviour in HCN channels. By including a short −70 mV pre-pulse prior to activation, the voltage-dependence of HCN1 channel activation is more depolarized by +14 mV. Cholesterol depletion or enrichment had no effect on HCN1 hysteresis (Fig. 5), which was corroborated by ramp protocols (Fig. 6). On the other hand, HCN2 channels showed no hysteresis in untreated cells, however, cholesterol depletion shifted the voltage-dependence of activation following the pre-pulse by +10–17 mV. Cholesterol enrichment also affected hysteresis in HCN2 channels with a small depolarizing shift observed (Fig. 6). Again these results were corroborated by examining hysteresis using ramp protocols in which we observed increased sensitivity to hysteresis upon cholesterol depeletion (Fig. 6). In HCN4 channels, a pre-pulse induced at +10 mV depolarizing shift in the voltage-dependence of activation, which was furthered an additional +5 mV with cholesterol enrichment (Table 1). Cholesterol regulation appears to differentially regulate the sensitivity or propensity for hysteresis or mode-shifting to occur in each isoform. In HCN1 channels, which readily undergo mode-shifting, the manipulation of cholesterol levels does not affect hysteresis. Cholesterol appears to make it easier for HCN4 channels to undergo mode-shifting, while mode-shifting appears more readily in HCN2 channels upon cholesterol depletion. Thus, it is evident that cholesterol regulates each isoform of human HCN channels uniquely.