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said the FDA asked the compang to do additional clinical studiez on itslead Gencaro. In saying that Gencaro didn’t prove it was the FDA also questioned the integrityof Arca’sd trial data based on an audit of some clinicalp trial sites. The FDA, however, said it had not reviewed several amendmentd that Arca filed in May to its new drug Gencaro — the centerpiece of a reverse mergee in January between Arca and Nuveloo — had been shelved by BMY) in 1999 after it didn’t show a significant statistical difference compared to a placebo.
Yet researchers latef discovered that some of the trial enrolleeswere hyper-responsivw to the drug due to common genetic Arca said it and had developed an accompanying genetic test to weed out patient who had that response. The revers merger with Nuvelo, which itselfv had stalled afterits clot-buster drug alfimeprase failed a late-stagse clinical trial in December 2006, made Arca publiclyu traded. The deal also gave Arca accessdto Nuvelo’s remaining Arca (NASDAQ: ABIO), based in Broomfield, Colo., nortgh of Denver, is led by Presidenr and CEO Richard Brewer, a Santa Cruz resident and former chief of Fremont’s Scios Inc.
Scios and its ill-fated heart failure drug Natrecor were sold six yearas ago tofor $2.3 billion.
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