The purpose of an end-of-Phase 2 meeting with the US FDA, is to ensure alignment with the regulatory agency and determine the pathway to Phase III. As part of the end-of-Phase 2 meeting, the US FDA reviews the adequacy of safety and efficacy, in previous non-clinical and clinical studies, and evaluates the plans for proceeding to Phase III. The US FDA may, in addition, note if any additional information is necessary to support a future marketing application. According to guidelines, the US FDA will respond to a request within 14 calendar days and schedule an end-of-Phase 2 meeting within 70 calendar days from receipt of the meeting request. IRLAB will communicate the meeting date once set by the US FDA.

“I am impressed that IRLAB, in close collaboration with international expert advisors, has been able to put together the Briefing Book based on the comprehensive data, including the important studies performed by Ipsen, in less than four months. I am pleased that this achievement has now led to this important milestone – submission of a request for an end-of-phase 2 meeting,” said Gunnar Olsson, CEO, IRLAB.

IRLAB is working together with the US advisory groups Clintrex, a clinical and regulatory strategy advisor; and ProPharma Group (PPG), IRLAB’s regulatory agent, to develop the strategy for the Phase III program and the Briefing Book for the end-of-Phase 2 meeting.