Macro Tsimmis

intelligently hedged investment

Neurocrine Biosciences (NBIX) update

Posted by intelledgement on Tue, 12 Jun 07

Neurocrine Biosciences (NBIX) announced after the close of the market today that they had resubmitted their new drug application (NDA) to the FDA for indiplon, their prospective insomnia product. The resubmitted NDA is a response to the approvable letter issued by the FDA in May 2006 with respect to the company’s original NDA for 5mg and 10mg dose capsules; the company is not currently responding to the nonapprovable letter issued back then for the 20mg tablets.

NBIX management expect the FDA to respond within six months.

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