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Replies to post #28718 on Biotech Values

Replies to #28718 on Biotech Values
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Jonathan Robinson

05/16/06 10:17 AM

#28720 RE: DewDiligence #28718

But there must have been some issue with the extended release version IMHO. The FDA often issues approvable when it means no approval, run more tests. Why issue a not approvable if it is simply a volume thing?

Jon
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AlpineBV_Miller

05/16/06 2:23 PM

#28746 RE: DewDiligence #28718

re: Indiplon moral?

See also ADLR's alvimopan for POI NDA.
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bio_neophyte

05/25/06 2:49 PM

#29205 RE: DewDiligence #28718

Dew - Indiplon moral?

What position are NBIX in now? Is it possible that the FDA will extent the PDUFA date? tia.