Palmitoyl Tetrapeptide-40

We rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to oversee most of the operations of our clinical trials and to perform data collection and analysis. As a result, we may face additional delays outside of our control if these parties do not perform their obligations in a timely fashion or in accordance with regulatory requirements. If these third parties do not successfully carry out their contractual duties or obligations and meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or for other reasons, our financial results and the commercial prospects for Aramchol or any other potential product candidates could be harmed, our costs could increase and our ability to obtain regulatory approval and commence product sales could be delayed.

Additional clinical trials may divert a significant amount of Company resources and may ultimately be unsuccessful.

We may experience rapid and substantial growth in order to achieve our operating plans, which will place a strain on our human and capital resources. Successful implementation of our business plan will require management of growth, which will result in an increase in the level of responsibility for management personnel. Although we have a relatively small number of employees, as we prepare for the ARMOR Study we have been increasing our operations, including expanding our employee base of managerial, operational, clinical and financial personnel. Any future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees. To that end, we must be able to, among other things:

We have incurred substantial losses since our inception. As of December 31, 2018, we had an accumulated deficit of approximately $86.5 million and working capital (current assets less current liabilities) of approximately $87.7 million. Due to our expectation that we will continue to not generate substantial revenues for the foreseeable future, we expect that losses will continue for the foreseeable future.

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Nevertheless, the present study has some limitations. (1) Proteomic analysis revealed that 8 function groups of proteins were differentially expressed after treatments, of which only oxidative stress and energy metabolism were evaluated in detail in present study regarding the relative contribution of each ingredient of QSYQ. However, some other proteins, such as those involved in apoptosis and inflammation, are also known as important determinants in progression of cardiac hypertrophy. The relative contribution of each ingredient of QSYQ to attenuate these insults remains unknown and needs further investigation; (2) QSYQ is composed of 4 herbs, each of which contains a number of active components. In addition to those that were evaluated in the present study, what is the contribution of other ingredients contained in each herbs to the effect of QSYQ remains to be explored.

Jeffery, T. K. & Morrell, N. W. Molecular and cellular basis of pulmonary vascular remodeling in pulmonary hypertension. Prog. Cardiovasc. Dis. 45, 173–202 (2002).

        Accordingly, assuming we, or any future collaborators, receive marketing approval for one or more of our product candidates, we, and any future collaborators, and our and their contract manufacturers will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control.

        Our future funding requirements, both short-term and long-term, will depend on many factors, including:

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Boor, P., Ostendorf, T. & Floege, J. Renal fibrosis: novel insights into mechanisms and therapeutic targets. Nature reviews Nephrology. 6, 643–656 (2010).

ADOCIA (Paris:ADOC.PA ) is a biotech company specialized in the development of best-in-class drugs from the innovative formulation of certain already-approved therapeutic proteins. Adocia is specialized in insulin therapy and the treatment of the diabetic foot, one of the main complications of diabetes. Worldwide, more than 366 million individuals are currently suffering from diabetes (with a forecast of 552 million individuals by 2030, i.e. a 51% increase, reaching 70% in emerging countries). 15% of these patients will develop a foot ulcer during their lifetime. The markets targeted by Adocia represent more than USD 20 billion (USD 17 billion for insulin therapy and USD 3 billion for diabetic foot ulcer healing). Through its BioChaperone® state-of-the-art technological platform, Adocia intends to enhance the effectiveness and safety of therapeutic proteins and their ease of use for patients, with the aim of making these medicines accessible to the broadest public. Adocia successfully completed two phases I and II studies on the formulation of a fast-acting human insulin and obtained promising phase I/II results on a diabetic foot ulcer-healing product. Adocia also confirmed the value of its technology for the formulation of a fast-acting insulin analog by signing an exclusive worldwide license agreement with a major pharmaceutical company. Furthermore, Adocia is developing a unique combination of fast-acting insulin and slow-acting insulin, for an optimal insulin therapy with one single product.

Hi Alan I can respect that. I have a philosophy degree so my thoughts go all over the place, but I must admit that fear of death motivates many of my musings.

Our President and Chief Executive Officer along with our principal shareholders, currently beneficially own approximately 34% of our outstanding ordinary shares as of December 31, 2018. Therefore, our principal shareholders will be able to exert significant control over matters submitted to our shareholders for approval. As a result, these shareholders, if they acted together, could significantly influence or even unilaterally approve matters requiring approval by our shareholders, including the election of directors and the approval of mergers or other business combination transactions. The interests of these shareholders may not always coincide with our interests or the interests of other shareholders. This significant concentration of share ownership may adversely affect the trading price for our ordinary shares because investors often perceive disadvantages in owning stock in companies with controlling shareholders.


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