MGC Pharmaceuticals to "move forward and speak to the FDA"
London, UK
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August 15, 2023 03:37 AM Eastern Daylight Time
MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) CEO and managing director Roby Zomer speaks to Thomas Warner from Proactive after the Europe-based plant-inspired medicine company announced the successful completion of a Pre-clinical Chronic Toxicology Evaluation of its immuno-modulation treatment CimetrA.
The study was undertaken on 32 domestic swine, that received a study treatment (three dosages groups of CimetrA® and Placebo) for 14 days.
Zomer describes the positive results from the trial as the "final piece of the puzzle" and says that MGC can now "move forward and speak to the FDA" about getting the treatment approved.
The CEO expresses optimism that the alignment of safety and efficacy results will facilitate a smooth interaction with the FDA and says he hopes to file in early 2024.
Zomer says that the results from the trial mean that "we have a quite straightforward line to speak to the FDA, and take [CimetrA] to the big league and get it approved in America.
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