JUN 21-22 ODAC

Potential pediatric development plans/written requests for: (1) APX - 005M, presentation by Apexigen, Inc.; (2) PMO1183 ( lurbinectedin ), presentation  by PharmaMar USA Inc.; (3) ASP2215  ( gilteritinib ), presentation by Astellas Pharma Global Development, Inc. (4) Prexasertib ,  presentation by Dista  Products/Eli Lilly and Company and (5)  olaratumab ,  presentation by Eli Lilly and  Company  

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MAY 18 PEDAC

Referral by an Institutional Review Board (IRB) of Sarepta's clinical investigation, entitled “A Double-Blind, Placebo-Controlled, 5 Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP- 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.”

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MAY 18 PEDAC

Referral by an Institutional Review Board (IRB) of Sarepta's clinical investigation, entitled “A Double-Blind, Placebo-Controlled, 5 Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP- 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.”

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