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Biotech / Medical : Biotech & Pharma.T.A, -- Ignore unavailable to you. Want to Upgrade?


To: Jibacoa who wrote (2049)12/13/2007 9:50:19 AM
From: Jibacoa  Respond to of 3722
 
NBIX is down 44.8% after announcing that it received a letter from the FDA requesting additional preclinical data before it would approve the NDA for indiplon 5 & 10 mg capsules for the treatment of insomnia.

bigcharts.marketwatch.com

The requirements are as follows:

An objective/subjective clinical trial in the elderly.
A safety study assessing the rates of adverse events occurring with indiplon when compared to a marketed product.
A preclinical study to evaluate indiplon administration during the third trimester of pregnancy.

Bernard



To: Jibacoa who wrote (2049)2/27/2008 11:46:04 AM
From: Jibacoa  Read Replies (1) | Respond to of 3722
 
MEDX is doing better after releasing its 4thQ results yesterday.

The stock is up 7.59% on volume of 1,405,615 > half its ADV

bigcharts.marketwatch.com

Revenues were significantly better at $20.5M vs. $11.3M. an improvement of 81%.The loss was cut some to $0.31/shr from $0/36/shr in 2006 But the EL for 2008 is higher, around $1.45/shr vs. the $1.20 loss in 2007

MEDX sold recently 2.5M shrs of Genmab for approximately $151.8M & still owns approximately 5.1% of Genmab.

The stock remains on a long term DT. Its March 2000 H was $103.<g>

bigcharts.marketwatch.com

Bernard