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Replies to #33208 on Biotech Values
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Jonathan Robinson

08/28/06 11:07 PM

#33222 RE: DewDiligence #33208

NBIX

You will see by my posts on the SI Board that I do not disagree with you on mgmt taking new options themselves later - effectively a double down strategy as they will keep old and take more new options than they would have.

I still do not believe this action telegraphs the FDA meetings. Management may have needed to act to keep employees in crisis mode. I do not see how it telegraphs bad news (which I personally think is more likely than not). It could telegraph delays in getting the meetings also by the way although they have said nothing recently about delays.

Jon
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Biowatch

09/05/06 7:59 AM

#33531 RE: DewDiligence #33208

Neurocrine says FDA seeks more details on sleep drug
Tue Sep 5, 2006 7:34 AM ET

Sept 5 (Reuters) - Neurocrine Biosciences Inc. (NBIX.O: Quote, Profile, Research) on Tuesday said U.S. regulators have asked for additional details related to its insomnia drug indiplon. The biopharmaceutical company said in an end-of-review meeting, the Food and Drug Administration requested the company to supplement the pharmacokinetic and food effect profile of indiplon capsules to include several meal types.

Neurocrine said it expects to re-submit the drug for marketing approval with the FDA before the end of the second quarter of 2007. (Reporting by Ankur Relia in Bangalore)