Isolagen:FDA seeks extra mid-stage trial for acne scar treatment
Nov 27 (Reuters) - Isolagen Inc (ILE.A: Quote, Profile, Research, Stock Buzz) said the U.S. Food and Drug Administration recommended an additional mid-stage study to address certain protocol issues and questions related to its Isolagen Therapy for treatment of moderate to severe acne scars.
The treatment is currently in late-stage trials and the company said it has modified its late-stage trial as a Phase II/III study. The FDA reiterated that there are no safety issues that would prevent the initiation of the proposed studies, it added. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Pratish Narayanan)
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