Medexus Pharmaceuticals Inc. ("Medexus" or the "Company") (
TSX:MDP.TO) (
OTCQX:MEDXF) today announced that it has scheduled a webinar on Thursday, August 5, 2021 at 10:00 a.m. Eastern Time to discuss the Complete Response Letter (CRL) that the Company's licensor, medac GmbH, recently received from the Food and Drug Administration (FDA) for treosulfan.
As previously disclosed, the New Drug Application (NDA) was submitted in respect of the use of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT). As expressed in the CRL, the FDA has determined that it cannot approve the NDA in its present form and has provided recommendations specific to additional clinical/statistical data and analyses pertaining to the primary and secondary endpoints of the completed pivotal Phase III study.
Medexus continues to be encouraged by the potential for approval of treosulfan by the FDA in the United States due to the acceptance by other agencies around the world and the excellent survival data that has been demonstrated for at-risk groups. The Company has scheduled the webinar to discuss the implications of the CRL and anticipated pathways to FDA approval. Ken d'Entremont, CEO, and Marcel Konrad, CFO will provide an overview of the CRL, followed by a question-and-answer period.