Recce, who have developed a unique technology have been invited to meet with the US Food and Drug Administration (FDA) to discuss its proposed clinical and regulatory pathway for its lead synthetic antibiotic compound RECCE 327.
The meeting, scheduled for early May, is set to take place at the FDA headquarters in Washington DC US and will include members of Recce’s technical and manufacturing teams, its FDA consultants Parexel International and infectious disease representatives of the FDA.
The invitation is an outcome of Recce’s recent additional technical data submission, which included a number of questions to the FDA relating to Recce’s proposed regulatory pathway of RECCE 327, including a Phase I clinical trial and beyond.
This initiative has been made with the view to open communications with the US regulator as the company seeks to set the regulatory pathway in a clear and expedient direction.
Recce’s lead compound RECCE 327 was awarded qualified infectious disease product (QIDP) designation in late 2017, which provides a process to drug sponsors for expedited review and 10 years of market exclusivity post-approval for products that treat serious or life-threatening infections.
Dr Graham Melrose, executive chairman at Recce, said: “Given the urgent medical need for new antibiotics, in the face of rising incidence of drug resistant superbugs, we look forward to meeting with the FDA to explore the most efficient regulatory pathway for RECCE 327.”
