This is great news! Particularly, as Dimerix already manufactures DMX200 in the USA with a FDA-approved manufacturer:
"MELBOURNE, Australia, 27 May 2019: Dimerix Limited (ASX: DXB), a clinical-stage biopharmaceutical company, provides an update on the Company’s activity relating to the commercial scale manufacturing of DMX-200. Commercial manufacturing capabilities secured with an FDA registered manufacturer, and demonstration batch manufacture completed Analytical methods developed and validated Commercial scale batch manufacture planned in FY2020 The development of Dimerix manufacturing capabilities has significantly progressed throughout the last quarter. The establishment of the commercial manufacturing process and the development of validated analytical methods for pharmaceutical grade DMX-200 is an essential component of the product development program and will support global marketing authorisations (including US FDA), commercialisation and partnering activities.
It is anticipated that DMX-200 would be the only pharmaceutical grade (GMP compliant), FDA approved medicine available to the patient, and at the approved dose. Dimerix has appointed an FDA approved, US based manufacturer for DMX-200 supply and has spent time carefully developing a pharmaceutical-grade method of manufacturing where impurities are strictly measured and controlled. Dimerix exclusively owns the intellectual property and know-how associated with the manufacturing processes and methodology for DMX-200 and has completed manufacture of a demonstration batch."
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