FDA won't seek more tests for Discovery drug
Philadelphia Inquirer, The, May, 2008 by Linda Loyd Inquirer Staff Writer
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On the first trading day after falling 50 percent, shares of Discovery Laboratories Inc. jumped 31 percent yesterday after the company clarified the status of its experimental respiratory drug for premature infants. The Warrington biotech company said Food and Drug Administration regulators would not require more clinical trials of its drug, Surfaxin.
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It said the FDA did raise quality-control issues, but the company would respond to them in six to eight weeks. Discovery Labs said it then hoped to get another review by the FDA in 60 days. Investors appeared heartened yesterday that Discovery Labs finally might get approved to sell Surfaxin, which would be its first FDA-approved drug. "Discovery Labs firmly believes that this recent approvable letter reflects notable progress toward gaining FDA approval," the company said. It was a stark reversal in market sentiment from Friday, when the company announced it had ...
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