The Cost Of Clinical Trials

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Expenses: The cost of clinical trials may cause Gilead earnings to fluctuate, which could adversely affect stock prices. Clinical trials are required to obtain regulatory approval of Gilead’s products, and clinical trials are generally required to be conducted after regulatory approval. Clinical trials are all very expensive and it is difficult to control or accurately predict the timing or amount of these expenses. In addition, the FDA and/or other regulatory agencies sometimes require more clinical testing than may have been originally planned. Unplanned spending on tests and clinical trials that may be necessary to further develop other product candidates may cause operational outcomes to fluctuate and result volatility in Gilead’s stock prices. Relationships: Gilead also depends on its relationships with other companies for product development and subsequent marketing and sales. Failure of these relationships, poor performance by those companies, or even disputes could negatively impact Gilead’s operations. Gilead relies on a number of collaborative relationships with other pharmaceutical companies for marketing and sales performance in certain geographic areas that include the United States, Europe and Canada, as well as territories outside of the United States. In some countries, Gilead relies on international distributors for sales of their products. Some relationships also involve the clinical development of partner products. Reliance on these relationships presents
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