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Biotech / Medical : Biotech Valuation
CRSP 53.98-2.0%3:59 PM EST

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To: Michael Young who wrote (10717)2/29/2004 3:46:48 PM
From: quidditch  Read Replies (1) 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
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