FDA wants more data on Neurocrine's indiplon

Neurocrine Biosciences has received more bad news from the FDA regarding its sleep drug indiplon. The biotech announced that regulators are looking for additional details and analyses on the therapeutic, signaling another delay in its release. The company announced that the FDA requested that Neurocrine "supplement the pharmacokinetic/food effect profile of indiplon capsules to include several meal types." Neurocrine plans to start a study after it completes talks with the FDA. Neurocrine shares slipped in early trading. Its stock had plunged over the summer after Pfizer pulled out of its collaboration with Neurocrine following the FDA's unwillingness to approve the 15 milligram dose of the drug without more data. Neurocrine, though, says it is pushing ahead and now plans to re-submit the drug for marketing approval by the end of the second quarter in 2007.

- here's the AP report on Neurocrine

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