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Examples
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Arca Biopharma gained 57 cents, or 13%, to 4.81, after the Broomfield, Colo., biopharmaceutical company said a trial showed its heart-failure treatment Gencaro demonstrated a near-significant overall survival benefit and a statistically significant benefit in slowing the progress of heart failure.
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Gencaro to be the first genetically targeted heart failure treatment and statements regarding the potential for personalized medicine to improve outcomes, increase efficacy, or decrease adverse events in cardiovascular patients.
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ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted heart failure treatment.
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These statements include, but are not limited to, statements regarding the ability of genetic variations to predict individual patient response to Gencaro, the potential for
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Arca had hoped to start selling Gencaro in 2010, but now will need to run a clinical trial of about 3,000 patients that's expected to stretch into 2013 - leaving the company scrambling for funding.
Dallas Business News - Local Dallas News | Dallas Business Journal 2010
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"As a result of the significant additional required development of Gencaro, including the additional clinical trial, we may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of Gencaro or to continue operations and may not be able to execute any strategic transaction," the company's 10-K states.
Dallas Business News - Local Dallas News | Dallas Business Journal 2010
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"We will need to complete a strategic transaction, such as a strategic combination or partnership of Gencaro commercialization rights, or raise substantial additional funding through public or private debt or equity markets to support the continued development of Gencaro, including the expected additional clinical trial," the filing adds.
Dallas Business News - Local Dallas News | Dallas Business Journal 2010
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"Even if we are able to fund continued development and Gencaro is approved, we expect that we will need to complete a strategic transaction or raise substantial additional funding through public or private debt or equity markets to successfully commercialize Gencaro."
Dallas Business News - Local Dallas News | Dallas Business Journal 2010
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It hired a commercial sales team in early 2009 in preparation for going to market with Gencaro.
Dallas Business News - Local Dallas News | Dallas Business Journal 2010
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Thursday, March 11, 2010, 9: 03am MST AstraZeneca still waiting for the upside to MedImmune acquisition Arca BioPharma Inc. -- which is struggling to get its experimental heart-failure drug Gencaro to market -- reported a "going concern" opinion from its accountants Thursday, and said it is considering a merger or other "strategic transaction."
Dallas Business News - Local Dallas News | Dallas Business Journal 2010
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