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Biotech / Medical : Biotech Valuation
CRSP 55.26+1.2%3:59 PM EST

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To: Doc Bones who wrote (13433)10/11/2004 9:47:48 AM
From: Biomaven  Read Replies (2) of 52153
 
Interesting presentation on the future of cancer clinical trials by Daniel von Hoff at the Arqule analyst day:

corporate-ir.net

His presentation is the first 25 minutes or so. He says the FDA is potentially moving to a new scheme for targeted drugs where the company has to show 25 responses out of 275 patients in order to get approval. So if you can figure out which patients your drug works in, you can get approval with small trials.

He also has some interesting things to say about Phase I and II trials. He says 4 months stable disease is a key response to aim for, and there should be less focus on PR's and CR's and more focus on quality of life issues for the patients. He argues for bigger Phase II's (75 patients) so you don't get failed Phase III's.

Well worth listening to.

Peter
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