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Biotech / Medical : Pharmacyclics (PCYC) -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (468)7/22/1999 10:49:00 PM
From: squetch  Read Replies (1) | Respond to of 717
 
Some Phase III Gd-Tex questions.
Any guesses as to when the 2/3 look will take place?

>>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.(:>)