Immunomedics (IMMU) - moderated Message Board

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Biotech / Medical : Immunomedics (IMMU) - moderated

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gaduntz73

immuapproval

To: weatherproof who wrote (36035)	6/18/2016 11:16:17 AM
From: li3511	2 Recommendations Read Replies (3) of 63324

> G makes it evident that OS will be critical in any consideration for AA I haven't been following this discussion closely, but with respect to this snippet of it ... it's gone off in the wrong direction. Overall Survival (OS) is the "gold standard" endpoint for a clinical trial. Typically, Accelerated Approval (AA) is granted on the basis of a "surrogate endpoint"—something other than overall survival. A surrogate endpoint is something that is reasonably believed to correlate with Overall Survival, but which can be studied more quickly. For cancer, it can include tumor shrinkage, survival rate after N years, etc. During the period of conditional, accelerated approval (during which marketing is allowed), the company conducts a longer study to see whether or not overall survival is actually improved.

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