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( AAAP ) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced that following the issuance of a previously disclosed Discipline Review Letter (DRL) in November, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. Similar to the DRL, the CRL refers to issues with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical datasets, which are precluding FDA reviewers from performing the required independent analysis of these clinical studies. In addition, the CRL requests subgroup analyses for gender, age and racial subgroups, as well as other stratification factors and important disease characteristics. A safety update on clinical and non-clinical studies, which is already in process, was also requested in the CRL. Finally, the CRL noted that any observations made during inspections of manufacturing facilities supporting the NDA need to be resolved prior to approval of the NDA. No additional clinical studies were requested in the CRL and there were no comments at this time on other sections of the NDA submission. click to readWe are pleased that the CRL reiterates the issues previously raised by the DRL, and does not contain any other significant requirements, stated Stefano Buono, Chief Executive Officer of AAA. Receiving the DRL in advance of the CRL was helpful, as we are already working on revising the datasets, and will incorporate the requested supplemental information into our resubmission. About Lutathera Lutathera (or lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue peptide currently in development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutathera belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting neuroendocrine tumors with radiolabeled somatostatin analogue peptides.

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