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Biotech / Medical : Biotech & Pharma.T.A,
BIB 83.68+0.1%Nov 28 4:00 PM EST

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To: Jibacoa who wrote (1727)12/11/2007 12:36:32 PM
From: Jibacoa  Read Replies (2) of 3722
 
MEDX Is down 20% after it & BMY reported yesterday data from the 3 registrational trials (008, 022, 007) that constitute the monotherapy program for ipilimumab in patients with metastatic melanoma.

bigcharts.marketwatch.com

The results from study 008, conducted under Special Protocol Assessment (SPA), did not meet the primary endpoint, which was to rule out a best objective response rate of less than 10 percent. However, the totality of data from the registrational program included a clear dose response effect observed in study 022 and best objective response rates across the 3 studies ranging from mid-single digits to mid-teens as determined by independent radiology review.

"Given the importance of these findings and the limited treatment options for this patient population, MEDX and BMY are planning to meet with regulatory agencies in the near future. Pending these discussions, the companies aim to submit a regulatory filing to the FDA in the first half of 2008".

A CC was scheduled for 8:00 AM today

Bernard
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