Investor Presentaiton

Content of Registration Dossier Module 5 Dossier Content Branded Generic New Drug Similar Drug Drug 5.1 Table of contents of Module 5 5.2 Tabular listing of all clinical studies 5.3 Clinical study reports 5.3.1 Reports of biopharmaceutic studies 5.3.2 Reports of human pharmacokinetic (PK) studies 5.3.3 Reports of human pharmacodynamic (PD) studies 5.3.4 Reports of efficacy and safety studies 5.3.5 Reports of post-marketing experience V V V V V V V V 5.3.6 Case report forms and individual patient listings V 5.4 Literature references used in Modulo 5 V BE Studies V V

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