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SKU: 87658160181
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Description

Krstevska M, Bosilkova G, Alabakovska S, Panov S, Orovchanec N

Two copies (homozygous) cause a ~ 70% reduction in enzyme function

After consideration of the public comment we received and our review of the application, we agree with the applicant and have determined that the SCOUT MD TM Delivery System meets the eligibility criterion at 419.66(b)(3)