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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Michael Young who wrote (10717)2/29/2004 3:46:48 PM
From: quidditch  Read Replies (1) | Respond to of 52153
 
Mike,

Rick, sales, Peter and others follow this closely. I recall estimates that indiplon NDA would be filed anywhere from six months to one year after FDA action on estorra. I just checked the NBIX website and (somewhat shockingly) it does not appear to have been updated recently: still refers to an NDA by year-end 2003 and reports on progress on the malignant glioma candidate (still in NBIX of course but to be out-licensed or otherwise disposed of).

My guess is that, with multiple P3s concluding, it will be by the end of this year.

A technical question: in the IR and MR forms of indiplon, can that be encompassed by one application or do the two release formulations require separate NDAs?

quid



To: Michael Young who wrote (10717)2/29/2004 9:55:46 PM
From: Harold Engstrom  Read Replies (2) | Respond to of 52153
 
Arformoterol and rest of pipe can be added to pending xop MDI...

Rick, do you have any opinion about SEP225382 for migraines...

H



To: Michael Young who wrote (10717)3/2/2004 4:59:03 PM
From: arnie h  Read Replies (1) | Respond to of 52153
 
<When will PFE file for indoplin?>
From Mar.1 PR.
SAN DIEGO -(Dow Jones)- Neurocrine Biosciences Inc. (NasdaqNM:NBIX - News) said a Phase III trial showed its indiplon drug is well tolerated in treating adults with transient insomnia and had no serious side effects.
The therapeutics developer will use data from this and other studies to support the new drug application it plans to submit to the Food and Drug Administration before July 1.