MEDXF - Medexus medac refile again for US approval of treosulfan for cancer patients undergoing stem-cell transplant

• Medexus Pharmaceuticals ( OTCQX:MEDXF ) its German partner medac resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for treosulfan following FDA's request for additional information related to the resubmitted NDA filed in April this year.
• The NDA seeks approval of treosulfan in combination with fludarabine as a preparative regimen for patients with certain types of cancer undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
• The companies said the current submission includes updates to data files and supporting information as requested by the FDA in May.
• "An FDA approval within a two- to six-month period from the acceptance date would then pave the way for a commercial launch of treosulfan in the United States in the first half of calendar year 2023," said Medexus' CEO Ken d’Entremont.

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