MXC - MGC Pharmaceuticals to move forward and speak to the FDA
(NewsDirect)
MGC Pharmaceuticals Ltd (LSE:MXC,OTC:MGCLF, ASX:MXC) CEO and managing director Roby Zomer speaks toThomas Warner from Proactive after the Europe-based plant-inspiredmedicine company announced the successful completion of a Pre-clinicalChronic Toxicology Evaluation of its immuno-modulation treatmentCimetrA.
The study was undertaken on32 domestic swine, that received a study treatment (three dosagesgroups of CimetrA® and Placebo) for 14 days.
Zomer describes the positive results fromthe trial as the "final piece of the puzzle" and says that MGCcan now "move forward and speak to the FDA" about getting thetreatment approved.
The CEOexpresses optimism that the alignment of safety and efficacy resultswill facilitate a smooth interaction with the FDA and says he hopes tofile in early 2024.
Zomer says that the results from the trialmean that "we have a quite straightforward line to speak to theFDA, and take [CimetrA] to the big league and get it approved inAmerica.
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