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Re: biotech_researcher post# 56734

Wednesday, 11/26/2014 1:22:40 PM

Wednesday, November 26, 2014 1:22:40 PM

Post# of 80490

Zuize, call me crazy, but usually the FDA would want the completion of the enrollment before making a decision on approval



We're referring to "Accelerated Approval", which does not require completing clinical trials. Below is the text on Accelerated Approval:

... Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate endpoint, or something that is thought to predict clinical benefit. Surrogate endpoints typically require less time, and in the case of a cancer patient, it is much faster to measure a reduction in tumor size, for example, than overall patient survival. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials ...


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