Investor Presentaiton

Structure of Registration Dossier In Brazil the registration dossier is structured in eCTD format and it has two main parts: Part 1- Administrative Part: It corresponds to Module 1 and includes compilation of all administrative data and local information Quality T Overall Summary 1 Regional Admin Information Module 1 Nonclinical Overview Nonclinical Summary I Clinical Overview Clinical Summary Part 2 - Technical Part: It corresponds to Module 2, Module 3, Module 4 and Module 5 that include summaries od pre-clinical studies; CMC information; nonclinical data and reports; and clinical information and reports. Module 2 Quality Nonclinical Study Reports Clinical Study Reports Module 3 Module 4 Module 5

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