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          Wikipedia  
          
                                   
                 
                                      author：focus   
                                        
                                      
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browse：79685
                                  
                                    
          
                                    
            
          
 
          FDA's Peter Marks talks with STAT's Adam Feuerstein
          Peter Marks, the FDA's top regulator of gene therapies (right), speaks with STAT's Adam Feuerstein in San Francisco.																									Sarah Gonzalez/Peopletography for STAT
          SAN FRANCISCO — Peter Marks, the Food and Drug Administration’s top regulator of gene therapies, seems very comfortable with granting some form of full approval to Elevidys, the Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy, based on his comments to me on Monday night during our “fireside chat” at a STAT event.
          To be clear, Marks declined to comment specifically about the ongoing FDA review of Elevidys. I tried. However, Marks described a “hypothetical case” in the context of my Sarepta questions that clearly suggested the failure of an Elevidys confirmatory study in October didn’t bother him all that much.
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          “Hypothetically, if you had a product that used an aggregate scale and all of the components of that aggregate scale looked pretty good, or nearly all of them look pretty good, but the aggregate, for various reasons, didn’t come out perfectly. We approved products based on that,” Marks told me.
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