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Biotech / Medical : Biotech Valuation
CRSP 55.08-2.9%Dec 26 9:30 AM EST

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To: Biomaven who wrote (1297)7/3/2000 2:50:10 AM
From: Miljenko Zuanic  Read Replies (2) of 52153
 
Peter,

<<Further, the FDA will be tougher (and hence slower) on a "new" new drug than on an "old" new drug.>>

Why?

NBIX candidate is Sonata *sister* (in theory) and (+)-Zopiclone is single enantiomer of the racemate, which never win FDA blessing. So, for FDA NBI34060 is “old” new (or me too) and (+)-Zopiclone is “new” new.

Both candidates will need one year safety data and 6 months large pivotal data. SEPR have small lead (4-6 months), but clinical data will dictate market success.

Somehow, I have gut-filing that NBI34060 is bit more than simple non-benzodiazepine hypnotic.

Miljenko
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