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Biotech / Medical : Neurocrine Biosciences (NBIX)
NBIX 141.80+0.6%Dec 31 3:59 PM EST

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To: Miljenko Zuanic who wrote (1138)6/7/2003 1:26:46 PM
From: Icebrg  Read Replies (1) of 1834
 
Miljenko

>> I do not understand why you are talking about Indiplon *disaster*, and what you make of it?>>

I was referring to the possibility that FDA might not approve Indiplon or that they would require additional testing that would delay the drug a couple of years.

I don't think this will happen, but it may well do. Indiplon will not be used for any life-threatening diseases and may very well be used almost in a chronic setting. Many users will be old, sick etc. FDA may therefore be very strict when evaluating the drug. Recent examples are what happened to Soltara and Cialis. Both drugs turned down for reasons that seemed to have caught management completely off-guard. They didn't know what FDA would be looking for and the roll-out of the drug was stopped. That's what I mean when I talk about a potential Indiplon disaster.

The odds are that this will not happen. But a cautious management will anyhow insure that if it does, it will not have too severe effects on remaining programs. They should be able to continue regardless. If they run into problems with FDA they will most probably also be able to collect less from Pfizer.

What is your opinion on CEPH by the way? Who/what would they be interested to buy?

Erik
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