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.

Advertisements

Leave a Reply

Please log in using one of these methods to post your comment:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

 
%d bloggers like this: