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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: Biotech Jim who wrote (9593)5/11/2003 8:46:22 PM
From: Vector1  Read Replies (1) of 9719
 
Jim, one of the big issues at the advisory committee was the duration of response. Bexxar and Zev have very similar response rates but somewhere between 15 and 20% of Bexxar patients have extremely durable complete responses; in excess of 5 years. The FDA was very skeptical but could not explain the small subpopulation that have lengthy remission. The FDA's reluctance related to the company's data and the quality of the data regarding those patients prior history. Remember, CRXA is seeking approval based on a comparison to prior chomo not a control group. However, many on the advisory committee were swayed by the long durations. If Bex can use length of duration in its sales pitch they will have a big advantage over Zev IMO.

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