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Biotech / Medical : Pharmacyclics (PCYC)

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To: squetch who wrote (469)	7/23/1999 1:11:00 AM
From: Miljenko Zuanic	Read Replies (1) of 717

....>>the median survival of patients with brain metastases treated with radiation therapy is approximately 3-4 months...The FDA has agreed that the proposed Phase III trial qualifies for "fast track" review, should efficacy end points be met. A single pivotal trial is adequate for approval, since survival, rather than a surrogate end point, is the primary end point of the study.<< What are those efficacy end points going to be? That maybe a stupid question, but it took me 10 months to think of it.(:>)... Predetermined percentage improvement in 1)clinical (objective, CR and PR[>50%]) response rate, 2)median time to disease progression, 3)median survival time and overall survival rate,... For 1) I will guess 20%, for 2)and 3) ~40-50%. The best will be to check with PCYC. Miljenko

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