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Re: Receives FDA Clearance to Begin Phase 2/3 Study of ARO-AAT for Treatment of Alpha-1 Liver Disease Here is a file from the FDA about adaptive trials. This is just draft guidance from September 2018, so I don't know if this is the latest approved information. While this method could speed up approval, it also introduces many variables into the trials and interpretations of data that can make it difficult to determine true safety and efficacy of the treatments. |
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Msg # | Subject | Author | Recs | Date Posted |
9976 | Re: Receives FDA Clearance to Begin Phase 2/3 Study of ARO-AAT for Treatment of Alpha-1 Liver Disease | btrane | 0 | 4/17/2019 10:36:10 AM |