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Biotech / Medical : Neurocrine Biosciences (NBIX) -- Ignore unavailable to you. Want to Upgrade?


To: zeta1961 who wrote (1618)6/25/2006 2:18:11 AM
From: Robohogs  Read Replies (2) | Respond to of 1834
 
Why doxepin?

On another note, I do think this one may be becoming safe to buy - 3 years burn rate covered and liklihood of some value in indiplon BUT be careful of some of the stuff being spewed out over on YMB. Pin is in overdrive like he has something to prove and not all of it is well thought out and researched. He is depending on SEPR comments as to when Ambien generic hits (April 2007 vs currently scheduled October 2006 - he should know the assumption - peds study ongoing or done to extend by 6 months).

He also says Ambien and Lunesta cause sleepwalking and driving and eating while indiplon does not. AND THIS is the crux of the matter: I think the safety data on 20 mg scared PFE/NBIX/FDA and the reason - very high amnesiac effect next day. This, ladies and gentlemen, is the culprit in the sleep-doing events. You do it and forget (i.e., amnesia). This effect from what I have seen may be higher in indiplon than in ambien and less of a worry for Lunesta. He is also saying safety data is better for indiplon, mainly using the driving study vs. the dual-isomer version of Lunesta as proof. Well, lunesta was approved and indiplon 15 mg was not - and if it only came down to efficacy data, FDA would have given an approvable with a new efficacy study needed.

The excuse for not applying for 20 mg approval given on the YMB is that 15 mg was all that was needed and they did not want to risk not approved. Well if indiplon is truly safer, 20 mg version should at least be as safe (and hence approvable). And they had the data for 20 mg dose.

So while Pin got ELN right (partly by luck as he still blames Avonex for PML and discounts some of the cases - I do think dual action was culprit but do think it will re-occur occasionally in mono as is being guided by FDA and companies), be careful of his bald statements.

Sorry for ranting but Pin lost some folks a lot of money in NBIX and while it may now be safe to enter the water, do it based on own due dili.

Despite my rants above, I will likely be dipping my toes back into the water (after losing 3 to DOVP).

Jon